Label: FAMOTIDINE injection
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NDC Code(s):
70771-1845-1,
70771-1845-7,
70771-1846-1,
70771-1846-6, view more70771-1847-1, 70771-1847-6
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 2, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Famotidine Injection USP, 40 mg/4 mL (10 mg/mL)
FOR THE PREPARATION OF INTRAVENOUS SOLUTIONS
10 X 4 mL Multiple-Dose Vials
Rx Only
Famotidine Injection USP, 40 mg/4 mL (10 mg/mL)
FOR THE PREPARATION OF INTRAVENOUS SOLUTIONS
4 mL Multiple-Dose Vials
Rx only
Famotidine Injection USP, 200 mg/20 mL (10 mg/mL)
FOR THE PREPARATION OF INTRAVENOUS SOLUTIONS
10 X 20 mL Multiple-Dose Vials
Rx only
Famotidine Injection USP, 200 mg/20 mL (10 mg/mL)
FOR THE PREPARATION OF INTRAVENOUS SOLUTIONS
20 mL Multiple-Dose Vials
Rx only
Famotidine Injection USP, 20 mg/2 mL (10 mg/mL)
FOR THE PREPARATION OF INTRAVENOUS SOLUTIONS
25 X 2 mL Single-Dose Vials
Rx only
Famotidine Injection USP, 20 mg/2 mL (10 mg/mL)
FOR THE PREPARATION OF INTRAVENOUS SOLUTIONS
2 mL Single-Dose Vials
Rx only
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INGREDIENTS AND APPEARANCE
FAMOTIDINE
famotidine injectionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1846 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE 40 mg in 4 mL Inactive Ingredients Ingredient Name Strength ASPARTIC ACID (UNII: 30KYC7MIAI) BENZYL ALCOHOL (UNII: LKG8494WBH) MANNITOL (UNII: 3OWL53L36A) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1846-6 10 in 1 CARTON 02/11/2024 1 NDC:70771-1846-1 4 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA215828 02/11/2024 FAMOTIDINE
famotidine injectionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1847 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE 200 mg in 20 mL Inactive Ingredients Ingredient Name Strength ASPARTIC ACID (UNII: 30KYC7MIAI) BENZYL ALCOHOL (UNII: LKG8494WBH) MANNITOL (UNII: 3OWL53L36A) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1847-6 10 in 1 CARTON 02/11/2024 1 NDC:70771-1847-1 20 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA215828 02/11/2024 FAMOTIDINE
famotidine injectionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1845 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE 20 mg in 2 mL Inactive Ingredients Ingredient Name Strength ASPARTIC ACID (UNII: 30KYC7MIAI) MANNITOL (UNII: 3OWL53L36A) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1845-7 25 in 1 CARTON 02/11/2024 1 NDC:70771-1845-1 2 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 ANDA215828 02/11/2024 Labeler - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 873671928 MANUFACTURE(70771-1846, 70771-1847, 70771-1845) , ANALYSIS(70771-1846, 70771-1847, 70771-1845)