FDA.reportPublic FDA data

NDC 0641-6023-01 - 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
0641-6023
Requested NDC
0641-6023-01
Package NDCs from labels
0641-6023-01, 0641-6023-10, 0641-6023-25
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
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
0641-6023-01Famotidine4 mL in 1 VIALINJECTION49
0641-6023-10Famotidine10 in 1 CARTONINJECTION109
0641-6023-25Famotidine25 in 1 CARTONINJECTION259

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6023FAMOTIDINE INJECTION [HIKMA PHARMACEUTICALS USA INC.]9Current NDC, Legacy NDC, 3 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
0641-6023-01ML - Milliliter0641-6023183ae172-b4ac-480e-8135-d9b16a1f558312013-02-13
0641-6023-10ML - Milliliter0641-60236cde6858-2b8c-4959-ada2-9a7fa27ee0c112024-03-12
0641-6023-25ML - Milliliter0641-6023dbcba5cb-ac3a-4338-b136-5a854336cb7712013-02-13

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 7 of 29 · 576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
berkley and jensen famotidineFAMOTIDINEBJWC93c857e4-72b3-433e-ae6f-281cd57e39962026-02-17WarningsExact identifier
unii: 5QZO15J2Z8
heartburn relief original strengthFAMOTIDINEMajor Pharmaceuticalsbe275c48-18bf-45f6-891d-36d89327813e2026-02-13WarningsExact identifier
unii: 5QZO15J2Z8
Pepcid AC Original StrengthFAMOTIDINEKenvue Brands LLC54f4086f-e443-4e7e-8c7e-94e152e1c2562026-02-06WarningsExact identifier
unii: 5QZO15J2Z8
acid reducerFAMOTIDINEH E B140f0e60-c809-4d86-a750-7649ee2881b52026-02-03WarningsExact identifier
unii: 5QZO15J2Z8
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dual Action CompleteFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDEMeijer Distribution Inc6e8ed233-9ffb-46f7-9632-d5bc3d3a558b2026-01-20WarningsExact identifier
unii: 5QZO15J2Z8
Walgreens Sterile Soothing Eye WashPURIFIED WATERWalgreensa62e3294-abd6-48dc-81b1-62a809bdc9682026-01-14WarningsExact identifier
unii: 059QF0KO0R
FamotidineFAMOTIDINEGLENMARK THERAPEUTICS INC., USA95f51f27-d367-4cfd-a15f-7856c9e361fb2026-01-13WarningsExact identifier
unii: 5QZO15J2Z8
equaline complete dual actionFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDEUnited Natural Foods, Inc. dba UNFIc32cb5be-e1f8-4510-8685-5e03a7d4224c2026-01-13WarningsExact identifier
unii: 5QZO15J2Z8
FAMOTIDINEFAMOTIDINEAurobindo Pharma Limited18066b80-1ec6-4092-80d9-70adb0ecac852026-01-09Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
FAMOTIDINEFAMOTIDINEBryant Ranch Prepack900b4fd6-9c62-4b64-b4db-760c49ae0a422026-01-09Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEAlembic Pharmaceuticals Inc.f149ecc1-d66c-42f9-a3f4-2ab6a522942b2026-01-09Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
unii: 059QF0KO0R
acid reliefFAMOTIDINERite Aid Corporation45789b7a-e9c7-4813-b07b-f88d9108455d2026-01-06WarningsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINENorthwind Health Company, LLCf2b6da72-72ea-d81b-e053-2995a90a95262026-01-01Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINENorthwind Health Company, LLCab1cdbbf-d838-020c-e053-2995a90a0f652026-01-01Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
Eye CleanEYE WASHHART Health41f53e2e-c2bc-4bf1-a541-3bcb2cf630022025-12-31WarningsExact identifier
unii: 059QF0KO0R
teeth and gumsCALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOSSiddha Flower Essences LLC926c79d5-d270-4c0d-aca9-b58571c24f3a2025-12-31WarningsExact identifier
unii: 059QF0KO0R
lung and sinusCALC PHOS, FERRUM PHOS, GENTIANELLA AMARELLA, FLOS, KALI MUR, KALI PHOS, KALI SULPH, ROCK WATER, ROSE CANINA, FLOSSiddha Flower Essences LLC9f7c949f-21bc-473c-ab8d-24837893fccc2025-12-31WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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