NDC Code(s) : 0409-1159-18, 0409-1159-01, 0409-1159-19, 0409-1159-02, 0409-1160-18, 0409-1160-01, 0409-1162-18, 0409-1162-01, 0409-1162-19, 0409-1162-02, 0409-1163-18, 0409-1163-01, 0409-1165-18, 0409-1165-01, 0409-1165-19, 0409-1165-02, 0409-9043-11, 0409-9043-01, 0409-9046-11, 0409-9046-01, 0409-9045-11, 0409-9045-01, 0409-9045-16, 0409-9045-17, 0409-9042-11, 0409-9042-01, 0409-9042-16, 0409-9042-17
Packager : Hospira, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-1159
Route of Administration EPIDURAL, INFILTRATION, INTRACAUDAL, PERINEURAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPIVACAINE HYDROCHLORIDE(UNII: 7TQO7W3VT8)
(BUPIVACAINE - UNII:Y8335394RO) 		BUPIVACAINE2.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE(UNII: 451W47IQ8X)8.6 mg in 1 mL
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0409-1159-0125 in 1 TRAY 05/06/2005
1NDC:0409-1159-1810 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
2NDC:0409-1159-0225 in 1 TRAY 15/08/2005
2NDC:0409-1159-1930 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070583 05/06/2005
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-1160
Route of Administration INFILTRATION, PERINEURAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPIVACAINE HYDROCHLORIDE(UNII: 7TQO7W3VT8)
(BUPIVACAINE - UNII:Y8335394RO) 		BUPIVACAINE2.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE(UNII: 451W47IQ8X)8.6 mg in 1 mL
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
METHYLPARABEN(UNII: A2I8C7HI9T)1 mg in 1 mL
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0409-1160-0125 in 1 TRAY 30/04/2005
1NDC:0409-1160-1850 mL in 1 VIAL, MULTI-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070590 04/30/2005
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-1162
Route of Administration EPIDURAL, INTRACAUDAL, PERINEURAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPIVACAINE HYDROCHLORIDE(UNII: 7TQO7W3VT8)
(BUPIVACAINE - UNII:Y8335394RO) 		BUPIVACAINE5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE(UNII: 451W47IQ8X)8.1 mg in 1 mL
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0409-1162-0125 in 1 TRAY 03/08/2006
1NDC:0409-1162-1810 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
2NDC:0409-1162-0225 in 1 TRAY 22/11/2005
2NDC:0409-1162-1930 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070584 11/22/2005
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-1163
Route of Administration PERINEURAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPIVACAINE HYDROCHLORIDE(UNII: 7TQO7W3VT8)
(BUPIVACAINE - UNII:Y8335394RO) 		BUPIVACAINE5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE(UNII: 451W47IQ8X)8.1 mg in 1 mL
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
METHYLPARABEN(UNII: A2I8C7HI9T)1 mg in 1 mL
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0409-1163-0125 in 1 TRAY 31/03/2005
1NDC:0409-1163-1850 mL in 1 VIAL, MULTI-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070597 03/31/2005
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-1165
Route of Administration EPIDURAL, RETROBULBAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPIVACAINE HYDROCHLORIDE(UNII: 7TQO7W3VT8)
(BUPIVACAINE - UNII:Y8335394RO) 		BUPIVACAINE7.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE(UNII: 451W47IQ8X)7.6 mg in 1 mL
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0409-1165-0125 in 1 TRAY 12/06/2005
1NDC:0409-1165-1810 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
2NDC:0409-1165-0225 in 1 TRAY 06/08/2005
2NDC:0409-1165-1930 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070585 06/08/2005
Bupivacaine Hydrochloride and EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-9043
Route of Administration INFILTRATION, PERINEURAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPIVACAINE HYDROCHLORIDE(UNII: 7TQO7W3VT8)
(BUPIVACAINE - UNII:Y8335394RO) 		BUPIVACAINE2.5 mg in 1 mL
EPINEPHRINE BITARTRATE(UNII: 30Q7KI53AK)
(EPINEPHRINE - UNII:YKH834O4BH) 		EPINEPHRINE5 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE(UNII: 451W47IQ8X)8.5 mg in 1 mL
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
METHYLPARABEN(UNII: A2I8C7HI9T)1 mg in 1 mL
SODIUM METABISULFITE(UNII: 4VON5FNS3C)0.1 mg in 1 mL
EDETATE CALCIUM DISODIUM ANHYDROUS(UNII: 8U5D034955)0.1 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0409-9043-0125 in 1 BOX 29/11/2005
1NDC:0409-9043-111 in 1 CARTON
150 mL in 1 VIAL, MULTI-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071167 11/29/2005
Bupivacaine Hydrochloride and EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-9046
Route of Administration PERINEURAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPIVACAINE HYDROCHLORIDE(UNII: 7TQO7W3VT8)
(BUPIVACAINE - UNII:Y8335394RO) 		BUPIVACAINE5 mg in 1 mL
EPINEPHRINE BITARTRATE(UNII: 30Q7KI53AK)
(EPINEPHRINE - UNII:YKH834O4BH) 		EPINEPHRINE5 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE(UNII: 451W47IQ8X)8.5 mg in 1 mL
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM METABISULFITE(UNII: 4VON5FNS3C)0.1 mg in 1 mL
METHYLPARABEN(UNII: A2I8C7HI9T)1 mg in 1 mL
EDETATE CALCIUM DISODIUM ANHYDROUS(UNII: 8U5D034955)0.1 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0409-9046-0125 in 1 BOX 26/07/2005
1NDC:0409-9046-111 in 1 CARTON
150 mL in 1 VIAL, MULTI-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071170 07/26/2005
Bupivacaine Hydrochloride and EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-9045
Route of Administration EPIDURAL, INTRACAUDAL, PERINEURAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPIVACAINE HYDROCHLORIDE(UNII: 7TQO7W3VT8)
(BUPIVACAINE - UNII:Y8335394RO) 		BUPIVACAINE5 mg in 1 mL
EPINEPHRINE BITARTRATE(UNII: 30Q7KI53AK)
(EPINEPHRINE - UNII:YKH834O4BH) 		EPINEPHRINE5 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE(UNII: 451W47IQ8X)8.5 mg in 1 mL
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM METABISULFITE(UNII: 4VON5FNS3C)0.1 mg in 1 mL
EDETATE CALCIUM DISODIUM ANHYDROUS(UNII: 8U5D034955)0.1 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0409-9045-0110 in 1 CARTON 09/08/2005
1NDC:0409-9045-1110 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
2NDC:0409-9045-1725 in 1 TRAY 21/03/2011
2NDC:0409-9045-1630 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071168 05/18/2005
Bupivacaine Hydrochloride and EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-9042
Route of Administration EPIDURAL, INFILTRATION, INTRACAUDAL, PERINEURAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPIVACAINE HYDROCHLORIDE(UNII: 7TQO7W3VT8)
(BUPIVACAINE - UNII:Y8335394RO) 		BUPIVACAINE2.5 mg in 1 mL
EPINEPHRINE BITARTRATE(UNII: 30Q7KI53AK)
(EPINEPHRINE - UNII:YKH834O4BH) 		EPINEPHRINE5 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE(UNII: 451W47IQ8X)8.5 mg in 1 mL
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM METABISULFITE(UNII: 4VON5FNS3C)0.1 mg in 1 mL
EDETATE CALCIUM DISODIUM ANHYDROUS(UNII: 8U5D034955)0.1 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0409-9042-0110 in 1 CARTON 26/08/2005
1NDC:0409-9042-1110 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
2NDC:0409-9042-1725 in 1 TRAY 21/03/2011
2NDC:0409-9042-1630 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071165 06/15/2005

LABELER - Hospira, Inc.(141588017)

Establishment
Name Address ID/FEI Business Operations
Hospira, Inc. 093132819 ANALYSIS(0409-1159, 0409-1160, 0409-1162, 0409-1163, 0409-1165, 0409-9042, 0409-9043, 0409-9045, 0409-9046), MANUFACTURE(0409-1159, 0409-1160, 0409-1162, 0409-1163, 0409-1165, 0409-9042, 0409-9043, 0409-9045, 0409-9046), PACK(0409-1159, 0409-1160, 0409-1162, 0409-1163, 0409-1165, 0409-9042, 0409-9043, 0409-9045, 0409-9046), LABEL(0409-1159, 0409-1160, 0409-1162, 0409-1163, 0409-1165, 0409-9042, 0409-9043, 0409-9045, 0409-9046)

Establishment
Name Address ID/FEI Business Operations
Hospira, Inc. 827731089 ANALYSIS(0409-1159, 0409-1160, 0409-1162, 0409-1163, 0409-1165, 0409-9042, 0409-9043, 0409-9045, 0409-9046)

Establishment
Name Address ID/FEI Business Operations
Hospira, Inc. 030606222 ANALYSIS(0409-9042, 0409-9043, 0409-9045, 0409-9046)

Establishment
Name Address ID/FEI Business Operations
Pfizer Healthcare India Private Limited 860037912 ANALYSIS(0409-1159, 0409-1160, 0409-1162, 0409-1163, 0409-1165), MANUFACTURE(0409-1159, 0409-1160, 0409-1162, 0409-1163, 0409-1165), PACK(0409-1159, 0409-1160, 0409-1162, 0409-1163, 0409-1165), LABEL(0409-1159, 0409-1160, 0409-1162, 0409-1163, 0409-1165)

PRINCIPAL DISPLAY PANEL

50 mL
Multiple-dose Fliptop Vial

0.25% Bupivacaine HCl
125 mg/50 mL (2.5 mg/mL)

and epinephrine
1:200,000 Injection

Bupivacaine and Epinephrine Inj., USP
FOR INFILTRATION AND NERVE BLOCK ONLY

Warning: Contains Sulfites

Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

LOT ##-###-AA
EXP DMMMYYYY

PRINCIPAL DISPLAY PANEL - 125 mg/50 mL Vial Label - 9043

PRINCIPAL DISPLAY PANEL

One/NDC 0409-9043-11

50 mL
Multiple-dose Fliptop Vial

Sterile, nonpyrogenic

0.25% Bupivacaine
Hydrochloride
125 mg/50 mL (2.5 mg/mL)

and epinephrine
1:200,000 Injection

Bupivacaine
and Epinephrine
Injection, USP
Rx only

FOR INFILTRATION AND
NERVE BLOCK ONLY

Not for caudal, epidural
or spinal anesthesia.

PROTECT FROM LIGHT.

Store in carton until
contents are used.

Warning: Contains Sulfites

Hospira

PRINCIPAL DISPLAY PANEL - 125 mg/50 mL Vial Carton - 9043

PRINCIPAL DISPLAY PANEL

10 mL Single-dose Teartop Vial
Rx only

0.5% Bupivacaine HCl
50 mg/10 mL (5 mg/mL)

and epinephrine 1:200,000 Injection

Bupivacaine Hydrochloride and
Epinephrine Injection, USP

FOR NERVE BLOCK, CAUDAL
AND EPIDURAL ANESTHESIA ONLY.

Warning: Contains Sulfites

Hospira

Dist. by Hospira, Inc., Lake Forest, IL 60045 USA

PRINCIPAL DISPLAY PANEL - 50 mg/10 mL Vial Label - 9045

PRINCIPAL DISPLAY PANEL

10 mL Single-dose Teartop Vial
Sterile, Nonpyrogenic
Rx only
NDC 0409-9045-01

Contains 10 of NDC 0409-9045-11

0.5% Bupivacaine Hydrochloride
50 mg/10 mL (5 mg/mL)

and epinephrine 1:200,000 Injection

Bupivacaine Hydrochloride and Epinephrine Injection, USP
FOR NERVE BLOCK, CAUDAL AND EPIDURAL ANESTHESIA ONLY.
Not for spinal anesthesia.

Each mL contains bupivacaine HCl, anhyd. 5 mg; epinephrine 5 mcg; sodium chloride 8.5 mg; sodium metabisulfite 0.1 mg added
as antioxidant; edetate calcium disodium, anhyd. 0.1 mg added as stabilizer. pH 4.0 (3.3 to 5.5). May contain HCl and/or NaOH for
pH adjustment. Contains no antimicrobial preservative. Discard unused portion after initial use.

Warning: Contains Sulfites

Hospira

PRINCIPAL DISPLAY PANEL - 50 mg/10 mL Vial Carton - 9045

PRINCIPAL DISPLAY PANEL

50 mL
Multiple-dose Vial

0.5% Bupivacaine HCl
250 mg/50 mL (5 mg/mL)

and epinephrine
1:200,000 Injection

Bupivacaine and Epinephrine Inj., USP

FOR NERVE BLOCK ONLY

Warning: Contains Sulfites

LOT ##-###-AA
EXP DMMMYYYY

PRINCIPAL DISPLAY PANEL - 250 mg/50 mL Vial Label - 9046

PRINCIPAL DISPLAY PANEL

One/NDC 0409-9046-11

50 mL
Multiple-dose Fliptop Vial

Sterile, nonpyrogenic

0.5% Bupivacaine
Hydrochloride
250 mg/50 mL (5 mg/mL)

and epinephrine
1:200,000 Injection

Bupivacaine
and Epinephrine
Injection, USP

FOR NERVE BLOCK ONLY.

Not for caudal, epidural
or spinal anesthesia.

Warning: Contains Sulfites

Hospira

PRINCIPAL DISPLAY PANEL - 250 mg/50 mL Vial Carton - 9046

PRINCIPAL DISPLAY PANEL

10 mL Single-dose Teartop Vial

0.25% Bupivacaine HCl
25 mg/10 mL (2.5 mg/mL)

and epinephrine
1:200,000 Injection

Bupivacaine Hydrochloride and
Epinephrine Injection, USP
Rx only

FOR INFILTRATION, NERVE BLOCK,
CAUDAL AND EPIDURAL ANESTHESIA.

Warning: Contains Sulfites

PRINCIPAL DISPLAY PANEL - 25 mg/10 mL Vial Label - 9042

PRINCIPAL DISPLAY PANEL

10 mL
Single-dose
Teartop Vial
Sterile, nonpyrogenic
Rx only
NDC 0409-9042-01

Contains 10 of NDC 0409-9042-11

0.25% Bupivacaine Hydrochloride
25 mg/10 mL (2.5 mg/mL)

and epinephrine 1:200,000 Injection

Bupivacaine Hydrochloride and Epinephrine Injection, USP
FOR INFILTRATION, NERVE BLOCK, CAUDAL AND EPIDURAL ANESTHESIA.
Not for spinal anesthesia.

Each mL contains bupivacaine HCl, anhyd. 2.5 mg; epinephrine 5 mcg; sodium chloride 8.5 mg; sodium
metabisulfite 0.1 mg added as antioxidant; edetate calcium disodium, anhyd. 0.1 mg added as stabilizer.
pH 4.0 (3.3 to 5.5). May contain HCl and/or NaOH for pH adjustment.
Contains no antimicrobial preservative. Discard unused portion after initial use.

Warning: Contains Sulfites
Hospira

PRINCIPAL DISPLAY PANEL - 25 mg/10 mL Vial Carton - 9042

PRINCIPAL DISPLAY PANEL

10 mL Single-dose Teartop Vial
Preservative-Free

0.25% Bupivacaine
Hydrochloride Injection, USP
25 mg/10 mL (2.5 mg/mL)

For INFILTRATION, NERVE BLOCK,
CAUDAL and EPIDURAL ANESTHESIA.

Not for intrathecal anesthesia.
Hospira

Dist. by Hospira, Inc., Lake Forest, IL 60045 USA

PRINCIPAL DISPLAY PANEL - 25 mg/10 mL Vial Label - 1159

PRINCIPAL DISPLAY PANEL

10 mL Single-dose Teartop Vial
Preservative-Free

Rx only
NDC 0409-1159-01
Contains 25 of NDC 0409-1159-18

0.25% Bupivacaine
Hydrochloride Injection, USP
25 mg/10 mL (2.5 mg/mL)

For INFILTRATION, NERVE BLOCK,
CAUDAL and EPIDURAL ANESTHESIA.

Not for intrathecal anesthesia.

PRINCIPAL DISPLAY PANEL - 25 mg/10 mL Vial Tray - 1159

PRINCIPAL DISPLAY PANEL

30 mL Single-dose Teartop Vial
Preservative-Free

0.25% Bupivacaine
Hydrochloride Injection, USP
75 mg/30 mL (2.5 mg/mL)

For INFILTRATION, NERVE BLOCK,
CAUDAL and EPIDURAL ANESTHESIA.

Not for intrathecal anesthesia.

Distributed by Hospira, Inc.
Lake Forest, IL 60045 USA
Hospira

PRINCIPAL DISPLAY PANEL - 75 mg/30 mL Vial Label - 1159

PRINCIPAL DISPLAY PANEL

30 mL Single-dose Teartop Vial
Preservative-Free

Rx only
NDC 0409-1159-02
Contains 25 of NDC 0409-1159-19

0.25% Bupivacaine
Hydrochloride Injection, USP
75 mg/30 mL (2.5 mg/mL)

For INFILTRATION,
NERVE BLOCK, CAUDAL
and EPIDURAL ANESTHESIA.

Not for intrathecal anesthesia.

PRINCIPAL DISPLAY PANEL - 75 mg/30 mL Vial Tray - 1159

PRINCIPAL DISPLAY PANEL

50 mL Multiple-dose Fliptop Vial

0.25% Bupivacaine
Hydrochloride Injection, USP
125 mg/50 mL (2.5 mg/mL)

For INFILTRATION and NERVE BLOCK.

Not for caudal, epidural or intrathecal anesthesia.

Distributed by Hospira, Inc.
Lake Forest, IL 60045 USA
Hospira

PRINCIPAL DISPLAY PANEL - 125 mg/50 mL Vial Label - 1160

PRINCIPAL DISPLAY PANEL

50 mL Multiple-dose Fliptop Vial

Rx only
NDC 0409-1160-01
Contains 25 of NDC 0409-1160-18

0.25% Bupivacaine
Hydrochloride Injection, USP
125 mg/50 mL (2.5 mg/mL)

For INFILTRATION and
NERVE BLOCK.

Not for caudal, epidural
or intrathecal anesthesia.

PRINCIPAL DISPLAY PANEL - 125 mg/50 mL Vial Tray - 1160

PRINCIPAL DISPLAY PANEL

10 mL Single-dose Teartop Vial
Preservative-Free

0.5% Bupivacaine
Hydrochloride Injection, USP
50 mg/10 mL (5 mg/mL)

For NERVE BLOCK, CAUDAL and EPIDURAL ANESTHESIA.

Not for intrathecal anesthesia.

Distributed by Hospira, Inc.
Lake Forest, IL 60045 USA
Hospira

PRINCIPAL DISPLAY PANEL - 50 mg/10 mL Vial Label - 1162

PRINCIPAL DISPLAY PANEL

10 mL Single-dose Teartop Vial
Preservative-Free

Rx only
NDC 0409-1162-01
Contains 25 of NDC 0409-1162-18

0.5% Bupivacaine
Hydrochloride Injection, USP
50 mg/10 mL (5 mg/mL)

For NERVE BLOCK, CAUDAL
and EPIDURAL ANESTHESIA.

Not for intrathecal anesthesia

PRINCIPAL DISPLAY PANEL - 50 mg/10 mL Vial Tray - 1162

PRINCIPAL DISPLAY PANEL

30 mL Single-dose Teartop Vial
Preservative-Free

0.5% Bupivacaine
Hydrochloride Injection, USP
150 mg/30 mL (5 mg/mL)

For NERVE BLOCK, CAUDAL and
EPIDURAL ANESTHESIA.

Not for intrathecal anesthesia.

Distributed by Hospira, Inc.
Lake Forest, IL 60045 USA
Hospira

PRINCIPAL DISPLAY PANEL - 150 mg/30 mL Vial Label - 1162

PRINCIPAL DISPLAY PANEL

30 mL Single-dose Teartop Vial
Preservative-Free

Rx only
NDC 0409-1162-02
Contains 25 of NDC 0409-1162-19

0.5% Bupivacaine
Hydrochloride Injection, USP
150 mg/30 mL (5 mg/mL)

For NERVE BLOCK, CAUDAL
and EPIDURAL ANESTHESIA.

Not for intrathecal anesthesia.

PRINCIPAL DISPLAY PANEL - 150 mg/30 mL Vial Tray - 1162

PRINCIPAL DISPLAY PANEL

50 mL Multiple-dose Fliptop Vial

0.5% Bupivacaine
Hydrochloride Injection, USP
250 mg/50 mL (5 mg/mL)

For NERVE BLOCK.

Not for caudal, epidural or intrathecal anesthesia.

Distributed by Hospira, Inc.,
Lake Forest, IL 60045 USA
Hospira

PRINCIPAL DISPLAY PANEL - 250 mg/50 mL Vial Label - 1163

PRINCIPAL DISPLAY PANEL

50 mL Multiple-dose Fliptop Vial

Rx only
NDC 0409-1163-01
Contains 25 of NDC 0409-1163-18

0.5% Bupivacaine
Hydrochloride Injection, USP
250 mg/50 mL (5 mg/mL)

For NERVE BLOCK.

Not for caudal, epidural
or intrathecal anesthesia.

PRINCIPAL DISPLAY PANEL - 250 mg/50 mL Vial Tray - 1163

PRINCIPAL DISPLAY PANEL

10 mL Single-dose Teartop Vial

0.75%
Bupivacaine
Hydrochloride Injection, USP
75 mg/10 mL (7.5 mg/mL)

For EPIDURAL and RETROBULBAR ANESTHESIA.

Not for OBSTETRIC or INTRATHECAL ANESTHESIA.

Dist. by Hospira, Inc. Lake Forest, IL 60045 USA

PRINCIPAL DISPLAY PANEL - 75 mg/10 mL Vial Label - 1165

PRINCIPAL DISPLAY PANEL

10 mL Single-dose Teartop Vial
Preservative-Free

Rx only
NDC 0409-1165-01
Contains 25 of NDC 0409-1165-18

0.75% Bupivacaine
Hydrochloride Injection, USP
75 mg/10 mL (7.5 mg/mL)

For EPIDURAL and
RETROBULBAR ANESTHESIA.

Not for OBSTETRIC or
INTRATHECAL ANESTHESIA.

PRINCIPAL DISPLAY PANEL - 75 mg/10 mL Vial Tray - 1165

PRINCIPAL DISPLAY PANEL

30 mL Single-dose Teartop Vial
Preservative-Free

0.75% Bupivacaine
Hydrochloride Injection, USP
225 mg/30 mL (7.5 mg/mL)

For EPIDURAL and RETROBULBAR ANESTHESIA.

Not for OBSTETRIC or INTRATHECAL ANESTHESIA.

Distributed by Hospira, Inc.,
Lake Forest, IL 60045 USA
Hospira

PRINCIPAL DISPLAY PANEL - 225 mg/30 mL Vial Label - 1165

PRINCIPAL DISPLAY PANEL

30 mL Single-dose Teartop Vial
Preservative-Free

Rx only
NDC 0409-1165-02
Contains 25 of NDC 0409-1165-19

0.75% Bupivacaine
Hydrochloride Injection, USP
225 mg/30 mL (7.5 mg/mL)

For EPIDURAL and RETROBULBAR ANESTHESIA.

Not for OBSTETRIC or INTRATHECAL ANESTHESIA.

PRINCIPAL DISPLAY PANEL - 225 mg/30 mL Vial Tray - 1165

PRINCIPAL DISPLAY PANEL

30 mL Single-dose Teartop Vial
Rx only

0.25% Bupivacaine HCl
75 mg/30 mL (2.5 mg/mL)

and epinephrine
1:200,000 Injection

Bupivacaine Hydrochloride
and Epinephrine Injection, USP

FOR INFILTRATION, NERVE BLOCK,
CAUDAL AND EPIDURAL ANESTHESIA.
Warning: Contains Sulfites

LOT ##-###-AA
EXP DMMMYYYY

PRINCIPAL DISPLAY PANEL - 75 mg/30 mL Vial Label - 9042

PRINCIPAL DISPLAY PANEL

30 mL Single-dose Teartop Vial

Rx only
NDC 0409-9042-17
Contains 25 of NDC 0409-9042-16

0.25% Bupivacaine Hydrochloride
75 mg/30 mL (2.5 mg/mL)
and epinephrine 1:200,000 Injection

Sterile, nonpyrogenic

Bupivacaine Hydrochloride and Epinephrine Injection, USP
FOR INFILTRATION, NERVE BLOCK, CAUDAL AND EPIDURAL ANESTHESIA.
Not for spinal anesthesia.
Warning: Contains Sulfites

Hospira

PRINCIPAL DISPLAY PANEL - 75 mg/30 mL Vial Tray - 9042

PRINCIPAL DISPLAY PANEL

30 mL Single-dose Teartop Vial
Discard unused portion

0.5% Bupivacaine HCl
150 mg/30 mL (5 mg/mL)

and epinephrine
1:200,000 Injection

Bupivacaine Hydrochloride and
Epinephrine Injection, USP

FOR NERVE BLOCK, CAUDAL
AND EPIDURAL ANESTHESIA ONLY.

Warning: Contains Sulfites

PRINCIPAL DISPLAY PANEL - 150 mg/30 mL Vial Label - 9045

PRINCIPAL DISPLAY PANEL

30 mL Single-dose Teartop Vial
Sterile, Nonpyrogenic

Rx only
NDC 0409-9045-17
Contains 25 of NDC 0409-9045-16

0.5% Bupivacaine Hydrochloride
150 mg/30 mL (5 mg/mL)
and epinephrine 1:200,000 Injection

Bupivacaine Hydrochloride and Epinephrine Injection, USP
FOR NERVE BLOCK, CAUDAL AND EPIDURAL ANESTHESIA ONLY.

Not for spinal anesthesia.
Warning: Contains Sulfites

PRINCIPAL DISPLAY PANEL - 150 mg/30 mL Vial Tray - 9045