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 17 of 29 · 576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FamotidineFAMOTIDINEWal-Mart Stores, Inc.018b02e8-1005-4736-a4fc-962881f52adf2025-03-15WarningsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEAurohealth LLC756c7234-6a63-4b1b-be36-2b1ed09e67a02025-03-15WarningsExact identifier
unii: 5QZO15J2Z8
Aspartame/MSG DetoxCHELIDONIUM MAJUS, ARNICA MONTANA, PHYTOLACCA DECANDRA, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, BISPHENOL A (BPA), DEXTROSE, MALTODEXTRIN, SUCRALOSE, ASPARTIC ACID, DIKETOPIPERAZINE, DOPAMINE HYDROCHLORIDE, FORMALINUM, FORMICUM ACIDUM, L-PHENYLALANINE, METHYL ALCOHOL, MONOSODIUM GLUTAMATEDeseret Biologicals, Inc.a1dc1bf3-db71-4550-a975-4f146fb940052025-03-11WarningsExact identifier
unii: 30KYC7MIAI
Bestmade Natural Products Field of Flowers FormulaAESCULUS CAR, AESCULUS HIP, AGRIMONIA EUP, BROMUS RAM, CALLUNA VULG, CARPINUS BET, CASTANEA SAT, CENTAURIUM UMB, CERATOSTIGMA WILLM, CICHORIUM INT, CLEMATIS VIT, FAGUS SYLV, GENTIANELLA AMARELLA, HELIANTHEMUM NUMMULARIUM, ILEX AQUIFOLIUM, IMPATIENS GLAND, LARIX DECIDUA, LONICERA CAPRIFOLIUM, MALUS, MIMULUS GUT, OLEA EUROP, ORNITHOGALUM UMB, PINUS SYL, POPULUS TREM, PRUNUS CERA, QUERCUS ROB, ROCK WATER, ROSA CAN, SALIX VIT, SCLERANTHUS ANNNUS, SINAPIS ARV, ULEX EURO, ULMUS PROC, VERBENA, VITIS VINBestmade Natural Products2fbf9b7c-e54f-589d-e063-6394a90a14a72025-03-07WarningsExact identifier
unii: 059QF0KO0R
FamotidineFAMOTIDINEAurobindo Pharma Limitedb0798337-1a73-415e-8416-613984ce5c652025-03-04Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
unii: 059QF0KO0R
FamotidineFAMOTIDINEGolden State Medical Supply, Inc.c72fad2e-3ffb-4f83-e053-2a95a90a3f9c2025-02-18Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
Advanced Eye Relief Eye WashWATER SOLUTIONBausch & Lomb Incorporated9caccce1-4530-441d-bf76-244edeb9dedc2025-02-17WarningsExact identifier
unii: 059QF0KO0R
heartburn reliefFAMOTIDINEMeijer Distribution Inc05c03fd8-abc8-47f7-868c-895b9a38c5b32025-02-17WarningsExact identifier
unii: 5QZO15J2Z8
acid reducerFAMOTIDINEPublix Super Markets Inca3ba9983-6747-45b2-b270-4ac1fb9d6e402025-02-17WarningsExact identifier
unii: 5QZO15J2Z8
acid controller original strengthFAMOTIDINECVS Pharmacyc7cb4e19-3442-45d2-b60a-87d4beea862a2025-02-13WarningsExact identifier
unii: 5QZO15J2Z8
heartburn reliefFAMOTIDINEMeijer Distribution Inc263ee489-fc3f-4578-b3a5-44f6d77578982025-02-13WarningsExact identifier
unii: 5QZO15J2Z8
kirkland signature acid controllerFAMOTIDINECostco Wholesale Companyd5d96078-ba87-4593-b15b-b7a646a8ab102025-02-12WarningsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINELEADER/ Cardinal Health 110, Inc.287525d8-83ef-7110-e063-6294a90ad3732025-02-11WarningsExact identifier
unii: 5QZO15J2Z8
Acid ControllerFAMOTIDINEH E Bcbe72270-b172-4662-9b9b-557e8cf53ffe2025-02-11WarningsExact identifier
unii: 5QZO15J2Z8
dg health heartburn prevention original strengthFAMOTIDINEDolgencorp, LLCf5c0ff75-77da-443c-a510-9c6a065ddc6c2025-02-11WarningsExact identifier
unii: 5QZO15J2Z8
foster and thrive acid reducerFAMOTIDINEStrategic Sourcing Services LLC9ff8539f-cdcd-4823-8baa-10a249c9220d2025-02-10WarningsExact identifier
unii: 5QZO15J2Z8
basic care acid reducerFAMOTIDINEAmazon.com Services LLC52e3b2f5-f3b9-4f4e-a70f-322eb04e6e8a2025-02-10WarningsExact identifier
unii: 5QZO15J2Z8
signature care acid controllerFAMOTIDINESafewayadbf2c58-cd1c-4444-b133-21a18a3489312025-02-10WarningsExact identifier
unii: 5QZO15J2Z8
basic care acid reducerFAMOTIDINEAmazon.com Services LLC0983cef7-b8b6-4ed9-a01e-c699fa6d2d062025-02-10WarningsExact identifier
unii: 5QZO15J2Z8

Reported adverse events (FAERS/openFDA)#

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