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FDA Drug information

FAMOTIDINE

Read time: 1 mins
Marketing start date: 19 Apr 2025
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Summary of product characteristics


Effective Time

20230802

Version

1

Spl Product Data Elements

FAMOTIDINE FAMOTIDINE FAMOTIDINE FAMOTIDINE ASPARTIC ACID BENZYL ALCOHOL MANNITOL WATER FAMOTIDINE FAMOTIDINE FAMOTIDINE FAMOTIDINE ASPARTIC ACID BENZYL ALCOHOL MANNITOL WATER FAMOTIDINE FAMOTIDINE FAMOTIDINE FAMOTIDINE ASPARTIC ACID MANNITOL WATER

Application Number

ANDA215828

Brand Name

FAMOTIDINE

Generic Name

FAMOTIDINE

Product Ndc

70771-1847

Product Type

HUMAN PRESCRIPTION DRUG

Route

INTRAVENOUS

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1846-6 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 NDC 70771-1846-1 Famotidine Injection USP, 40 mg/4 mL (10 mg/mL) FOR THE PREPARATION OF INTRAVENOUS SOLUTIONS 4 mL Multiple-Dose Vials Rx only NDC 70771-1847-6 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 NDC 70771-1847-1 Famotidine Injection USP, 200 mg/20 mL (10 mg/mL) FOR THE PREPARATION OF INTRAVENOUS SOLUTIONS 20 mL Multiple-Dose Vials Rx only NDC 70771-1845-7 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 NDC 70771-1845-1 Famotidine Injection USP, 20 mg/2 mL (10 mg/mL) FOR THE PREPARATION OF INTRAVENOUS SOLUTIONS 2 mL Single-Dose Vials Rx only 40 mg/4 mL (10 mg/mL) carton label 40 mg/4 mL (10 mg/mL) vial label 200 mg/20 mL (10 mg/mL) carton label 200 mg/20 mL (10 mg/mL) vial label 20 mg/2 mL (10 mg/mL) carton label 20 mg/2 mL (10 mg/mL) vial label

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