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 13 of 29 · 576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ACID CONTROLLERFAMOTIDINESafeway9ddfb9fd-1b84-4e9a-90b5-6a3362d345dd2025-08-13WarningsExact identifier
unii: 5QZO15J2Z8
UP AND UP DUAL ACTION ACID REDUCER ANTACIDFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDETarget Corporation8e925e57-9036-4658-bf07-578e22675af82025-08-11WarningsExact identifier
unii: 5QZO15J2Z8
Acid Reducer Plus AntacidFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDECVS Pharmacyd6f0b82c-3890-4e85-8b8a-354fb8d0b6402025-08-11WarningsExact identifier
unii: 5QZO15J2Z8
Acid Reducer Plus AntacidFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDECVS Pharmacy509435e4-14fd-4e09-bdc1-ad295b46806b2025-08-11WarningsExact identifier
unii: 5QZO15J2Z8
FAMOTIDINEFAMOTIDINEAscend Laboratories, LLCbe69d9f9-f4ad-4cfe-bab2-e07186b25c1e2025-08-07Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
acid controllerFAMOTIDINESafewayf3d08f06-a676-43b0-8f77-611f0af737a72025-08-07WarningsExact identifier
unii: 5QZO15J2Z8
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEPreferred Pharmaceuticals Inc.e2f29ca9-9ec8-4b82-8c80-8628d9e3ab2f2025-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
FAMOTIDINEFAMOTIDINEMicro Labs Limited1756ab7d-05c4-4726-8f72-4e83634409682025-07-29Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
Welmate Famotidine 20mgFAMOTIDINE 20MGYYBA Corp1ea3c6b6-4c1e-d93c-e063-6394a90a0dac2025-07-29WarningsExact identifier
unii: 5QZO15J2Z8
Welmate Famotidine 10mgFAMOTIDINE 10MGYYBA Corp1e19d0cc-65d7-8ec4-e063-6394a90a3d2a2025-07-29WarningsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEChain Drug Marketing Association INC7fbc5e10-30c6-7f8d-1040-d48a80fe4d792025-07-22WarningsExact identifier
unii: 5QZO15J2Z8
Acid Reducer Original StrengthFAMOTIDINEDr.Reddys Laboratories Inc.ca039876-f7e5-3e60-da5a-a1f40637a4172025-07-17WarningsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEAlbertsons Companies27314f55-5e31-703c-b98c-ec89bf3084722025-07-17WarningsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEFamily Dollar Stores, Inc.0f81e8ac-ddad-13d6-e883-6a5310e058de2025-07-17WarningsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEDiscount Drug Mart, Incc5d81352-c45b-3ea1-9974-8a096bd050092025-07-17WarningsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEChain Drug Consortium, LLC937f7bce-955b-9418-5aed-2e84aee50de32025-07-17WarningsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEChain Drug Marketing Association INC1d78bc9e-cf7b-8853-c6dc-b36e5de4dd0a2025-07-17WarningsExact identifier
unii: 5QZO15J2Z8
equate famotidineFAMOTIDINEWALMART INC.f38f8a8f-3292-4fe5-b83f-ffd634196d422025-07-16WarningsExact identifier
unii: 5QZO15J2Z8
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEPHOENIX RX LLC397f1f23-10c2-569e-e063-6394a90a71642025-07-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
Sterile WaterSTERILE WATERNephron Pharmaceuticals Corporationbc04a883-babc-87a6-e053-2995a90a3dfd2025-07-11Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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