FDA.reportPublic FDA data

NDC 0641-6021-01 - 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
0641-6021
Requested NDC
0641-6021-01
Package NDCs from labels
0641-6021-01, 0641-6021-10
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
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
0641-6021-01Famotidine20 mL in 1 VIALINJECTION209
0641-6021-10Famotidine10 in 1 CARTONINJECTION109

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6021FAMOTIDINE 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
0641-6021-01ML - Milliliter0641-6021613a20d9-c98f-4731-9be1-7db259da908712013-02-13
0641-6021-10ML - Milliliter0641-60216ed8396c-a368-4580-9b5c-58077e01468d12013-02-13

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 6 of 29 · 576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FamotidineFAMOTIDINEBryant Ranch Prepack545d5c1f-ec1c-4135-965f-333ad888d96f2026-03-31Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
GOOD SENSE DUAL ACTION COMPLETEFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDEL. Perrigo Companyb5a36da3-7316-493c-b50f-fc5393d858c02026-03-24WarningsExact identifier
unii: 5QZO15J2Z8
Acid Reducer Maximum StrengthFAMOTIDINE 20MGGrocery Outlet0c85b203-3d09-4799-97a9-722ee207bbfb2026-03-20WarningsExact identifier
unii: 5QZO15J2Z8
ACID REDUCER COMPLETEFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDEWalgreen Companyb94b16d3-b52f-4d70-bbb0-d9fb074c891c2026-03-19WarningsExact identifier
unii: 5QZO15J2Z8
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
FamotidineFAMOTIDINEPreferred Pharmaceuticals Inc.fd5d15b9-b1b5-48ef-ba41-8a43a7642e942026-03-17Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
acid reducer original strengthFAMOTIDINEHyVee Inca0f2683f-59ad-4f65-a108-696430d577ab2026-03-16WarningsExact identifier
unii: 5QZO15J2Z8
Pepcid CompleteFAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDEKenvue Brands LLCe874118f-b4fe-4c80-aece-99ea20e7e8052026-03-12WarningsExact identifier
unii: 5QZO15J2Z8
complete dual actionFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDEHyVee Inc237efe92-b302-4e11-93fe-7b0f727a00aa2026-03-12WarningsExact identifier
unii: 5QZO15J2Z8
ACID REDUCERFAMOTIDINEPublix Super Markets Inc3455be3c-696e-402a-a5df-830544fa525a2026-03-11WarningsExact identifier
unii: 5QZO15J2Z8
STYE EYE RELIEF SERUMVITAMIN E, LYSINEGuangzhou Mizi Biotechnology Co., LTD.4c592b9b-53ad-4fe6-e063-6294a90ae9792026-03-06WarningsExact identifier
unii: 30KYC7MIAI
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
Walgreens Unscented Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLWalgreen Co.41eadb4f-2ca5-42a1-e063-6294a90ab4e22026-03-04WarningsExact identifier
unii: LKG8494WBH
Acid Reducer CompleteFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDEWalgreen Company6f1dcfda-c12a-4c3b-80a2-c9e15517c88f2026-03-03WarningsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINELegacy Pharmaceutical Packaging, LLCcc88fbdc-546e-332f-e053-2995a90a8ca72026-03-03Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
Acid Controller Original StrengthFAMOTIDINEWalgreen Company98c6ddc9-8103-40b3-a145-ffbe3374ab6c2026-03-03WarningsExact identifier
unii: 5QZO15J2Z8
Equate FamotidineFAMOTIDINEWal-Mart Stores Inc8ac94821-aa78-4e57-bc9a-f1f2a0e47b072026-03-03WarningsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEProficient Rx LPd60bde93-f512-4071-9e4b-1d8318def3bc2026-03-01Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
acid controllerFAMOTIDINEWalgreen Companyc16d9977-39ad-4386-8867-72aab97c99d52026-02-28WarningsExact identifier
unii: 5QZO15J2Z8

Reported adverse events (FAERS/openFDA)#

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