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 22 of 29 · 576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Original strength heartburn preventionFAMOTIDINEKROGER COMPANYea1c2838-acbd-18e0-e053-2a95a90a35222024-07-08WarningsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEContract Pharmacal Corp.273deac8-c2b0-423f-8662-4f16d91df2162024-07-04Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
FAMOTIDINEFAMOTIDINENuCare Pharmaceuticals,Inc.fd271deb-c748-bf26-e053-6294a90a11aa2024-06-28Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.ad42a7e3-84ea-390d-e053-2a95a90a3a322024-06-14WarningsExact identifier
unii: 059QF0KO0R
FamotidineFAMOTIDINENuCare Pharmaceuticals,Inc.60cd0973-f74e-2b70-e053-2a91aa0a43612024-06-06Adverse reactionsExact identifier
unii: 5QZO15J2Z8
Eyes Alive Eye WashWATERRIVIERA PHARMA INC081079f4-1c06-4054-b771-00fedaa666f62024-06-05WarningsExact identifier
unii: 059QF0KO0R
FamotidineFAMOTIDINEA-S Medication Solutions0abfc8e6-7fdf-4828-89f4-2202002f84892024-06-03Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEA-S Medication Solutions75a334ee-48b9-47e7-8225-6e595bed8a742024-06-03Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
PepcidFAMOTIDINEBausch Health US LLCa06502d9-7903-4f37-833e-e5763d502def2024-06-01Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
Sterile WaterWATERBecton Dickinson and Company6e43c5a3-dad2-49ed-b500-964cb4563cc92024-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
FamotidineFAMOTIDINERising Pharma Holdings, Inc.15b87f7f-1abf-4d8a-bdbe-03bea0021a682024-05-29Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEVKT Pharma Private Limited1c2cfb3c-eaa0-403f-9589-d706afc06f512024-05-22WarningsExact identifier
unii: 5QZO15J2Z8
Maximum Strength Acid ReducerFAMOTIDINETARGET CORPORATION07a924f1-14cc-4e7d-e063-6394a90ac7f32024-05-13WarningsExact identifier
unii: 5QZO15J2Z8
Walgreens Lidocaine Plus CreamBENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDEWalgreens Companye33e0097-31d6-8083-e053-2a95a90af5d22024-05-09WarningsExact identifier
unii: LKG8494WBH
HealthWise Lidocaine Plus CreamBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDEVeridian Healthcare16f26249-b508-2c6e-e063-6394a90a265b2024-04-25WarningsExact identifier
unii: LKG8494WBH
IBUPROFEN AND FAMOTIDINEIBUPROFEN AND FAMOTIDINEAdvanced Rx Pharmacy of Tennessee, LLC16c8b0db-37d0-99d9-e063-6394a90ac31b2024-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
PEMF OptimizerAQUA SULIS, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, LAPIS ALBUS, MANGANUM METALLICUM VANADIUM METALLICUM VISCUM ALBUM, ZINCUM METALLICUMDeseret Biologicals, Inc.97d57469-4c5b-4d3f-9398-3a1a6617a6492024-04-23WarningsExact identifier
unii: 059QF0KO0R
Pepcid CompleteFAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDENavajo Manufacturing Company Incac3cd760-4615-117b-e053-2a95a90a8d422024-04-15WarningsExact identifier
unii: 5QZO15J2Z8
Zantac 360FAMOTIDINENavajo Manufacturing Company Inc.e328c59c-baed-0e4e-e053-2995a90ab85c2024-04-15WarningsExact identifier
unii: 5QZO15J2Z8
FAMOTIDINEFAMOTIDINEAsclemed USA, Inc.69bd5340-298b-46ca-83c7-0b5ef233f9c52024-04-12Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8

Reported adverse events (FAERS/openFDA)#

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