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 20 of 29 · 576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zantac 360, Travel BASIXFAMOTIDINE TABLET, FILM-COATEDLil' Drug Store Products, Incea38535a-c9db-d03f-e053-2a95a90adf2d2024-11-19WarningsExact identifier
unii: 5QZO15J2Z8
Meijer Pain Lidocaine Plus Relieving AnalgesicBENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDEMeijer Distribution, Incb7385140-3f63-4cbc-b557-de1d29d1ea362024-11-15WarningsExact identifier
unii: LKG8494WBH
PEPCID AC Maximum StrengthFAMOTIDINEKenvue Brands LLC2854047f-c5c4-43c3-8ef2-5c0a84a307f22024-11-11WarningsExact identifier
unii: 5QZO15J2Z8
Maximum Strength PEPCID AC Icy Cool MintFAMOTIDINEKenvue Brands LLC0f343092-4fc7-1fff-e063-6294a90aba6e2024-11-11WarningsExact identifier
unii: 5QZO15J2Z8
dg health heartburn preventionFAMOTIDINEDolgencorp Inc679cdecb-9e25-4f43-b4f4-7f5f3fbf22962024-11-11WarningsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEUpsher-Smith Laboratories, LLCd528fadf-316f-4fea-9bec-070c01f80d642024-11-08Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
Crane Safety Eye WashWATER SOLUTIONCrane Safety LLC96d8dda9-6cd6-3f68-e053-2995a90a0da22024-11-08WarningsExact identifier
unii: 059QF0KO0R
RUGBY EYE WASHWATER, PURIFIEDA-S Medication Solutions0773e558-2f46-494c-888a-3bc517202b652024-11-08WarningsExact identifier
unii: 059QF0KO0R
FamotidineFAMOTIDINEAlembic Pharmaceuticals Limited7c0f3fa5-0a44-4a98-bc43-8bff8e95c4622024-10-31Adverse reactionsExact identifier
unii: 5QZO15J2Z8
Acid ReducerFAMOTIDINEAllegiant Health5c6c6665-cb0a-41d1-af28-85b4f061bd1b2024-10-30WarningsExact identifier
unii: 5QZO15J2Z8
ChemtoxTRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE,BioActive Nutritional, Inc.9aa060f1-f8f6-46e6-a7d0-bd46a73f26762024-10-17WarningsExact identifier
unii: LKG8494WBH
EyS Eye WashWATEREyes-Plus LLC1443f6bf-3a77-4a19-8585-0ec58efe042f2024-10-15WarningsExact identifier
unii: 059QF0KO0R
Eye WashWATER SOLUTIONKroger Company354402ad-581d-47e7-9fd3-933bef281ff42024-10-11WarningsExact identifier
unii: 059QF0KO0R
Eye WashWATERHubei Changjian Medical Products Co., Ltd.d57e1c5b-1edc-4a94-88bc-f9ecf347b7ea2024-10-11WarningsExact identifier
unii: 059QF0KO0R
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEPar Health USA, LLCb6895176-efb1-472e-8b6f-2987e8e676842024-10-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEBryant Ranch Prepackee69d3cb-dc95-410c-a7c8-6623073a923d2024-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
Fast Freeze Lidocaine Roll-OnLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLNatural Essentials, Inc.74b06366-5eb4-4eba-aa2b-2b672828294d2024-10-04WarningsExact identifier
unii: LKG8494WBH
CVS Health Lidocaine Plus Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLNATURAL ESSENTIALS, INC.1adb9b74-4a01-4461-b845-f3aedcb3f8102024-10-01WarningsExact identifier
unii: LKG8494WBH
Famotidine 10 mgFAMOTIDINE 10 MGMARKSANS PHARMA LIMITED58b653eb-6539-4b79-9d22-df6eaf35307f2024-09-30WarningsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEAmerican Health Packaging3a583080-6771-4246-a221-2491e9e5d8af2024-09-24Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8

Reported adverse events (FAERS/openFDA)#

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