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 4 of 29 · 576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FamotidineFAMOTIDINEPreferred Pharmaceuticals Inc.32fd4101-15cb-411e-8b9d-270ec0592c6e2026-06-08Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
unii: 059QF0KO0R
FamotidineFAMOTIDINEST. MARY'S MEDICAL PARK PHARMACY31cdc900-fe17-2d5f-e063-6294a90a0fda2026-06-08Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINESagent Pharmaceuticals9710995d-b518-40ce-bc2b-8b5dcf002c312026-06-06Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
acid reliefFAMOTIDINERite Aid Corporation8c6d5419-088b-4b3e-80b8-2a0d06926ff12026-06-03WarningsExact identifier
unii: 5QZO15J2Z8
ACID REDUCERFAMOTIDINEHyVee Inc381db08e-5756-4255-8202-1d8e6a1cf0382026-06-03WarningsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINESt. Mary's Medical Park Pharmacyf175822d-7ca4-fa33-e053-2995a90ac3102026-06-02Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
Good Neighbor Pharmacy Dual Action CompleteFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDEAmerisource Bergenb7453c0e-b452-409b-a324-83fdd105bfd02026-06-02WarningsExact identifier
unii: 5QZO15J2Z8
Pepcid CompleteFAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDESavings Distributors LLC549136d5-8f2c-d417-e063-6394a90a23e42026-06-01WarningsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEProficient Rx LP68d21d95-9603-4e68-855a-bfc65b1b58c32026-06-01Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
Dual Action CompleteFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDEMeijer Distribution Inc50fe57e1-6678-4697-9b35-4673db67d4fb2026-06-01WarningsExact identifier
unii: 5QZO15J2Z8
FAMOTIDINEFAMOTIDINEA-S Medication Solutionse53928f3-5181-490b-acfb-be8d4cea60a92026-05-29Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
FAMOTIDINEFAMOTIDINEA-S Medication Solutions05b47b1d-f7f3-4dae-9b22-d43d2a7cfaef2026-05-29Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
CareOne Acid ReliefFAMOTIDINEAmerican Sales Company206f5483-7de1-4bc3-af27-190e211bcb952026-05-21WarningsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEBryant Ranch Prepackcf2cd30e-9a0f-4b63-975c-5b551691cda92026-05-21Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
FamotidineFAMOTIDINEA-S Medication Solutionsd0558e97-3bc3-4a1e-9248-1959b03440232026-05-19Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEBryant Ranch Prepackdb3af7cc-efc6-4934-acff-8bb2d31fe8292026-05-19Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
good sense acid reducerFAMOTIDINEL. Perrigo Companycc77f6ff-a534-4731-b971-4912808408992026-05-18WarningsExact identifier
unii: 5QZO15J2Z8

Reported adverse events (FAERS/openFDA)#

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