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 27 of 29 · 576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FamotidineFAMOTIDINEFresenius Kabi USA, LLC5995d726-f3f8-4c2d-af19-1b12e3f769c62022-10-20Warnings, Adverse reactionsExact identifier
rxcui: 204441
unii: 5QZO15J2Z8
Eye washPURIFIED WATERMcKessonbd089fde-24ba-4de5-e053-2995a90a39bb2022-10-18WarningsExact identifier
unii: 059QF0KO0R
famotidineFAMOTIDINECamber Consumer Care Incebe3ca30-df25-4c56-8935-414a3431b5b92022-10-11WarningsExact identifier
unii: 5QZO15J2Z8
topcare acid reducerFAMOTIDINETopco Associates LLC7824fdab-cdd5-457d-9b14-b82b19ea95292022-10-03WarningsExact identifier
unii: 5QZO15J2Z8
Bach Original Flower Remedies Rock WaterWATERNelson Bach USA Limitedea242559-1618-3354-e053-2a95a90a1a952022-10-03WarningsExact identifier
unii: 059QF0KO0R
FAMOTIDINEFAMOTIDINEHF Acquisition Co LLC, DBA HealthFirst9948991d-9405-c7c8-e053-2995a90a60ca2022-10-01Adverse reactionsExact identifier
rxcui: 1743833
unii: 5QZO15J2Z8
Sterile WaterWATERMedical Purchasing Solutions, LLCe90b47e3-9636-b9ee-e053-2a95a90ad48c2022-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
famotidineFAMOTIDINENavinta LLC0f34a3be-7554-4040-b808-5ba8bf064abc2022-09-17Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
injoy heartburn reliefFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDEL. Perrigo Companyaca1b9e5-a35e-4eef-b55a-4189cd1b2a022022-09-07WarningsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEProficient Rx LPf32d0929-de22-4bec-9e24-bb549cf2679f2022-09-01Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
Zantac 360 2 per blister 6 blistersFAMOTIDINEJC World Bell Wholesale Co., Inc.fd61a2d6-5c8a-4e7a-8b19-37406b90f7782022-08-15WarningsExact identifier
unii: 5QZO15J2Z8
Premasol - sulfite-free (Amino Acid)LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDEBaxter Healthcare Company9afdcc3e-0d06-47f4-86ca-40da48b2b02b2022-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 30KYC7MIAI
signature care acid reducer completeFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDESafeway885f43ab-5c14-417b-aab7-e887dfc48f2e2022-07-20WarningsExact identifier
unii: 5QZO15J2Z8
dg health acid reducerFAMOTIDINEDolgencorp Inc3ffa405e-bc85-4614-afd0-7a8dfc288dad2022-07-13WarningsExact identifier
unii: 5QZO15J2Z8
Dual Action CompleteFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDEKroger Company522a256b-a7c0-4783-bfff-3dc6b5a2b3152022-07-12WarningsExact identifier
unii: 5QZO15J2Z8
Equate Acid Reducer CompleteFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDEWal-Mart Stores Inc3400c3aa-15f2-4279-9623-72933298b3dd2022-07-12WarningsExact identifier
unii: 5QZO15J2Z8
Basic Care Dual Action CompleteFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDEAmazon.com Services LLC27235c87-2fe9-458f-8eb0-b9880199cd5a2022-07-11WarningsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEProficient Rx LPc84b0ba3-1ba8-4da9-b5b8-186e01cda9992022-07-01Adverse reactionsExact identifier
unii: 5QZO15J2Z8
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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