FDA.reportPublic FDA data

Famotidine Injection, USP Rx Only

Manufacturer
Zydus Lifesciences Limited
Effective date
2023-08-02
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:11:36

Label at a glance#

ProductFAMOTIDINE
Active ingredientFAMOTIDINE
Label structure1 sections

Label contents#

Full prescribing information#

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

40 mg/4 mL (10 mg/mL) carton label
40 mg/4 mL (10 mg/mL) carton label

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

40 mg/4 mL (10 mg/mL) vial label
40 mg/4 mL (10 mg/mL) vial label

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

200 mg/20 mL (10 mg/mL) carton label
200 mg/20 mL (10 mg/mL) carton label

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

200 mg/20 mL (10 mg/mL) vial label
200 mg/20 mL (10 mg/mL) vial label

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

20 mg/2 mL (10 mg/mL) carton label
20 mg/2 mL (10 mg/mL) carton label

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

20 mg/2 mL (10 mg/mL) vial label
20 mg/2 mL (10 mg/mL) vial label

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1845FAMOTIDINE INJECTION [ZYDUS LIFESCIENCES LIMITED]1Unmatched20240211_cf3aa86f-c6da-4bd3-ad1c-2a2cb0067f05.zip
70771-1846FAMOTIDINE INJECTION [ZYDUS LIFESCIENCES LIMITED]1Unmatched20240211_cf3aa86f-c6da-4bd3-ad1c-2a2cb0067f05.zip
70771-1847FAMOTIDINE INJECTION [ZYDUS LIFESCIENCES LIMITED]1Unmatched20240211_cf3aa86f-c6da-4bd3-ad1c-2a2cb0067f05.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70771-184670771-1846-1, 70771-1846-6
70771-184770771-1847-1, 70771-1847-6
70771-184570771-1845-1, 70771-1845-7

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
FAMOTIDINE5QZO15J2Z8ACTIB
ASPARTIC ACID30KYC7MIAIIACT
BENZYL ALCOHOLLKG8494WBHIACT
MANNITOL3OWL53L36AIACT
WATER059QF0KO0RIACT
FAMOTIDINE5QZO15J2Z8ACTIB
ASPARTIC ACID30KYC7MIAIIACT
BENZYL ALCOHOLLKG8494WBHIACT
MANNITOL3OWL53L36AIACT
WATER059QF0KO0RIACT
FAMOTIDINE5QZO15J2Z8ACTIB
ASPARTIC ACID30KYC7MIAIIACT
MANNITOL3OWL53L36AIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
dbd7324f-4601-41c7-afd0-999b0900e479cf3aa86f-c6da-4bd3-ad1c-2a2cb0067f052025-06-03Exact identifier
spl set id: cf3aa86f-c6da-4bd3-ad1c-2a2cb0067f05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.