FDA.reportPublic FDA data

NDC 0641-6022-01 - Famotidine

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0641-6022
Requested NDC
0641-6022-01
Package NDCs from labels
0641-6022-01, 0641-6022-25
Manufacturer
Hikma Pharmaceuticals USA Inc.
Effective date
2024-04-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Famotidine Injection, USPHikma Pharmaceuticals USA Inc.2024-04-09HUMAN PRESCRIPTION DRUG LABEL
Famotidine - Medical Purchasing Solutions, LLCMedical Purchasing Solutions, LLC2023-05-08HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-6022-01Famotidine2 mL in 1 VIALINJECTION29
0641-6022-25Famotidine25 in 1 CARTONINJECTION259

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6022FAMOTIDINE INJECTION [HIKMA PHARMACEUTICALS USA INC.]9Current NDC, Legacy NDC, 2 package rows20240410_1fdf16e5-145d-4c19-a318-fc6c10794b50.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6022-01ML - Milliliter0641-602214529626-4b70-42c6-a890-9b69073ec03a12013-02-13
0641-6022-25ML - Milliliter0641-60224387b354-0e9e-4478-9b06-72f87bf78c5812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FAMOTIDINEACTIVE INGREDIENT5QZO15J2Z8FAMOTIDINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
FAMOTIDINEACTIVE MOIETY5QZO15J2Z8FAMOTIDINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
ASPARTIC ACIDINACTIVE INGREDIENT30KYC7MIAIFAMOTIDINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHFAMOTIDINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AFAMOTIDINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
WATERINACTIVE INGREDIENT059QF0KO0RFAMOTIDINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1

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 18 of 29 · 576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
equaline heartburn preventionFAMOTIDINEUnited Natural Foods, Inc. dba UNFI4b78d0c8-7d0c-45e6-9b36-b248f002f2b82025-02-10WarningsExact identifier
unii: 5QZO15J2Z8
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products, Inc.2d90c8e8-f479-3535-e063-6394a90af1222025-02-07WarningsExact identifier
unii: 059QF0KO0R
Major Heartburn Relief Maximum StrengthFAMOTIDINEMajor Pharmaceuticalsee0a263e-3f78-4534-9a30-803de636f92b2025-02-06WarningsExact identifier
unii: 5QZO15J2Z8
Equate FamotidineFAMOTIDINEWal-Mart Stores Inc15973213-0e11-4d18-b437-50b0a593cb7b2025-02-06WarningsExact identifier
unii: 5QZO15J2Z8
FAMOTIDINEFAMOTIDINENuCare Pharmceuticals,Inc.fc603d56-6828-8c5e-e053-6394a90a35bd2025-02-05Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINENuCare Pharmaceuticals,Inc.0786d7f5-85a7-d835-e063-6394a90ad7192025-02-03Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEProficient Rx LPc7327748-835b-44df-848f-8c620d327ce62025-02-01Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
Bestmade Natural Products BM63CEANOTHUS, KALI MUR, KALI ARS, OOPHRINUM, SELENIUM, THALLIUM, WEISBADENBestmade Natural Products2cea4552-3700-3da3-e063-6294a90a14b52025-01-30WarningsExact identifier
unii: 059QF0KO0R
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEAdvanced Rx of Tennessee, LLC2cf7412a-7f94-e39f-e063-6294a90a5bc22025-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINENCS HealthCare of KY, LLC dba Vangard Labs59b17677-d805-4d9e-9c64-96385ae47bff2025-01-27Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
Medics Choice Soothing Eye WashPURIFIED WATERKC Pharmaceuticals, Inc.10e49808-161e-f4ec-e063-6294a90a17752025-01-19WarningsExact identifier
unii: 059QF0KO0R
FAMOTIDINEFAMOTIDINEdirect rxb1b82d2a-cdb5-3e22-e053-2995a90a917d2025-01-17Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
FAMOTIDINEFAMOTIDINEdirect rxc3de241e-6217-d6e0-e053-2a95a90a35c52025-01-17Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEAvPAKdfdca61d-8824-6230-e053-2995a90a209d2025-01-09Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
STERILE WATERSTERILE WATERHF Acquisition Co. LLC, DBA HealthFirst74ed2a6f-824c-a1ff-e053-2a91aa0a57c02025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst77bd3c0f-f4ab-7cfa-e053-2a91aa0a1b832025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst7610bf80-61b7-982f-e053-2a91aa0ac1bb2025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
T-27WATERDNA Labs, Inc.f0e9afd7-64a4-4b85-9c5f-4bf07ba4b4812025-01-09WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATER FOR INJECTIONMedefil, Inc.99e99a50-82d5-aff6-e053-2a95a90a8c562025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BACTERIOSTATIC WATERBACTERIOSTATIC WATERHF Acquisition Co LLC, DBA HealthFirst99b0ef9b-600a-40dc-e053-2a95a90aa07e2025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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