NDC Code(s) : 0069-0121-01, 0069-0121-02, 0069-0125-01, 0069-0125-02, 0069-0126-01, 0069-0126-02
Packager : Pfizer Laboratories Div Pfizer Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

FamotidineFAMOTIDINE INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-0121
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAMOTIDINE(UNII: 5QZO15J2Z8)
(FAMOTIDINE - UNII:5QZO15J2Z8) 		FAMOTIDINE10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ASPARTIC ACID(UNII: 30KYC7MIAI)
MANNITOL(UNII: 3OWL53L36A)
BENZYL ALCOHOL(UNII: LKG8494WBH)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0069-0121-0225 in 1 CARTON
1NDC:0069-0121-012 mL in 1 VIAL, SINGLE-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078642 05/10/2011
FamotidineFAMOTIDINE INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-0125
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAMOTIDINE(UNII: 5QZO15J2Z8)
(FAMOTIDINE - UNII:5QZO15J2Z8) 		FAMOTIDINE10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ASPARTIC ACID(UNII: 30KYC7MIAI)
MANNITOL(UNII: 3OWL53L36A)
BENZYL ALCOHOL(UNII: LKG8494WBH)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0069-0125-0210 in 1 CARTON
1NDC:0069-0125-014 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078641 05/10/2011
FamotidineFAMOTIDINE INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-0126
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAMOTIDINE(UNII: 5QZO15J2Z8)
(FAMOTIDINE - UNII:5QZO15J2Z8) 		FAMOTIDINE10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ASPARTIC ACID(UNII: 30KYC7MIAI)
MANNITOL(UNII: 3OWL53L36A)
BENZYL ALCOHOL(UNII: LKG8494WBH)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0069-0126-0210 in 1 CARTON
1NDC:0069-0126-0120 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078641 05/10/2011

PRINCIPAL DISPLAY PANEL

20 mg/2 mL

NDC 0069-0121-01

2 mL Single-Dose Vial

famotidine injection, USP
20 mg/2 mL (10 mg/mL)

Sterile
For Intravenous Use
Only After Dilution.

Rx only

PRINCIPAL DISPLAY PANEL - 20 mg/2 mL Vial Label

PRINCIPAL DISPLAY PANEL

NDC 0069-0121-02
Contains 25 of NDC 0069-0121-01
Rx only

25 x 2 mL Single-Dose Vials

famotidine injection, USP
20 mg/2 mL (10 mg/mL)

Sterile

For Intravenous Use Only After Dilution.

Pfizer Injectables

20 mg/2 mL

PRINCIPAL DISPLAY PANEL - 20 mg/2 mL Vial Carton

PRINCIPAL DISPLAY PANEL

NDC 0069-0125-01

4 mL Multi-dose Vial

Famotidine
Injection, USP
40 mg/4 mL
(10 mg/mL)

For Intravenous Use
Only After Dilution.

Rx only
Sterile

PRINCIPAL DISPLAY PANEL - 40 mg/4 mL Vial Label

PRINCIPAL DISPLAY PANEL

NDC 0069-0125-02
Contains 10 of NDC 0069-0125-01
Rx only

10 x 4 mL Multi-dose Vial

Famotidine Injection, USP
40 mg/4 mL
(10 mg/mL)

Sterile

For Intravenous Use Only After Dilution.

Pfizer Injectables

PRINCIPAL DISPLAY PANEL - 40 mg/4 mL Vial Carton

PRINCIPAL DISPLAY PANEL

NDC 0069-0126-01

20 mL Multi-dose Vial

Famotidine
Injection, USP
200 mg/20 mL
(10 mg/mL)

Sterile
For Intravenous Use
Only After Dilution.

Rx only

PRINCIPAL DISPLAY PANEL - 200 mg/20 mL Vial Label

PRINCIPAL DISPLAY PANEL

NDC 0069-0126-02
Contains 10 of NDC 0069-0126-01
Rx only

10 x 20 mL Multi-dose Vial

Famotidine Injection, USP
200 mg/20 mL
(10 mg/mL)

Sterile

For Intravenous Use Only After Dilution.

Pfizer Injectables

PRINCIPAL DISPLAY PANEL - 200 mg/20 mL Vial Carton