NDC Code(s) : 0409-7337-11, 0409-7337-01, 0409-7338-11, 0409-7338-01, 0409-7332-11, 0409-7332-01, 0409-7335-13, 0409-7335-03
Packager : Hospira, Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Ceftriaxone SodiumCeftriaxone Sodium INJECTION, POWDER, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-7337
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFTRIAXONE SODIUM(UNII: 023Z5BR09K)
(CEFTRIAXONE - UNII:75J73V1629) 		CEFTRIAXONE250 mg
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0409-7337-0110 in 1 CARTON 05/09/2005
1NDC:0409-7337-111 in 1 VIAL, SINGLE-USE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065169 05/09/2005
Ceftriaxone SodiumCeftriaxone Sodium INJECTION, POWDER, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-7338
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFTRIAXONE SODIUM(UNII: 023Z5BR09K)
(CEFTRIAXONE - UNII:75J73V1629) 		CEFTRIAXONE500 mg
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0409-7338-0110 in 1 CARTON 05/09/2005
1NDC:0409-7338-111 in 1 VIAL, SINGLE-USE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065169 05/09/2005
Ceftriaxone SodiumCeftriaxone Sodium INJECTION, POWDER, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-7332
Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFTRIAXONE SODIUM(UNII: 023Z5BR09K)
(CEFTRIAXONE - UNII:75J73V1629) 		CEFTRIAXONE1 g
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0409-7332-0110 in 1 CARTON 05/09/2005
1NDC:0409-7332-111 in 1 VIAL, SINGLE-USE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065169 05/09/2005
Ceftriaxone SodiumCeftriaxone Sodium INJECTION, POWDER, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-7335
Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFTRIAXONE SODIUM(UNII: 023Z5BR09K)
(CEFTRIAXONE - UNII:75J73V1629) 		CEFTRIAXONE2 g
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0409-7335-0310 in 1 CARTON 05/09/2005
1NDC:0409-7335-131 in 1 VIAL, SINGLE-USE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065169 05/09/2005

LABELER - Hospira, Inc(141588017)

PRINCIPAL DISPLAY PANEL

250mg-carton

NDC 0409-7337-01

Ceftriaxone for

Injection, USP

250 mg

Rx Only

For I.M. or I.V. Use

10 Single-Dose Vials

Hospira

PRINCIPAL DISPLAY PANEL

500mg-carton

NDC 0409-7338-01

Ceftriaxone for

Injection, USP

500 mg

Rx Only

For I.M. or I.V. Use

10 Single-Dose Vials

Hospira

PRINCIPAL DISPLAY PANEL

1-gram-carton

NDC 0409-7332-01

Ceftriaxone for

Injection, USP

1 gram

Rx Only

For I.M. or I.V. Use

10 Single-Dose Vials

Hospira

PRINCIPAL DISPLAY PANEL

2gm-carton

NDC 0409-7335-03

Ceftriaxone for

Injection, USP

2 grams

Rx Only

For I.M. or I.V. Use

10 Single-Dose Vials

Hospira