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 23 of 29 · 576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERHikma Pharmaceuticals USA Inc.78ef7ad3-451d-43d0-a9b6-5cf0aadca0032024-04-10Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERB. Braun Medical Inc.8fc8d87a-3951-4ac5-97df-c161ffc904752024-04-10Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
FamotidineFAMOTIDINEHikma Pharmaceuticals USA Inc.1fdf16e5-145d-4c19-a318-fc6c10794b502024-04-09Warnings, Adverse reactionsExact identifier
application number: ANDA075486
application number: ANDA075488
ndc (package): 0641-6023-01
ndc (package): 0641-6022-25
ndc (package): 0641-6023-10
ndc (package): 0641-6021-01
ndc (package): 0641-6023-25
ndc (package): 0641-6021-10
ndc (package): 0641-6022-01
ndc (product): 0641-6022
ndc (product): 0641-6021
ndc (product): 0641-6023
ndc11 (package): 00641602201
rxcui: 204441
rxcui: 1743833
spl id: 021158a6-1da8-477a-af20-4ce26c147b32
spl set id: 1fdf16e5-145d-4c19-a318-fc6c10794b50
unii: 5QZO15J2Z8
Eye WashWATERM-star (Hubei) Health&Care Products Co., Ltd.71706039-e250-4f08-9687-71b2928c4e462024-04-01WarningsExact identifier
unii: 059QF0KO0R
famotidineFAMOTIDINECHAIN DRUG MARKETING ASSOCIATION, INC.6daf1ebe-b0a2-4413-bf25-3de6eb64b0c62024-03-27WarningsExact identifier
unii: 5QZO15J2Z8
ULINE EyewashEYEWASHUline.14545fc9-1fb4-befa-e063-6294a90a04742024-03-23WarningsExact identifier
unii: 059QF0KO0R
FamotidineFAMOTIDINEDirect_Rx138d9ed1-2f8f-d19d-e063-6394a90a695d2024-03-13Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
FAMOTIDINEFAMOTIDINENuCare Pharmaceuticals,Inc.13168d9e-0697-e5fb-e063-6294a90a69ba2024-03-07Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
Maximum Strength Acid ReducerFAMOTIDINETIME CAP LABORATORIES,INCfe25e1e2-7158-6fe0-e053-6394a90a3bb12024-03-06WarningsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEDR. REDDY'S LABORATORIES INC88ac92eb-5684-46c8-8cd2-3d4aefee26cf2024-02-22Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
GI DrainageCINNAMOMUM, GENTIANA LUTEA, SYZYGIUM JAMBOLANUM, ARGENTUM NITRICUM, COLCHICUM AUTUMNALE, COLOSTRUM (BOVINE), COPPER GLUCONATE, LAPPA MAJOR, LYCOPODIUM CLAVATUM, MAGNESIUM GLUCONICUM, MANGANESE GLUCONATE, PANCREAS SUIS, POTASSIUM GLUCONATE, RUMEX CRISPUS, STOMACH (SUIS), AURUM METALLICUM, CALCAREA CARBONICA, CARBO VEGETABILIS, INTESTINE (SUIS), MALUS PUMILA, FLOS, NITRICUM ACIDUM, PRUNUS CERASIFERA, FLOS, ROCK WATER, SCHROPHULARIA NODOSA, FAGUS SYLVATICA, FLOSDeseret Biologicals, Inc.ff81e3ca-2f88-4daf-a734-083107269d3a2024-02-21WarningsExact identifier
unii: 059QF0KO0R
FamotidineFAMOTIDINEAmneal Pharmaceuticals NY LLC443e8ea6-7d51-4db7-8f0b-7a854d45bf232024-02-13Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
Sterile WaterSTERILE WATERChartwell RX, LLC3681eeaa-807a-47ca-9fbc-61c2b682800a2024-02-01Exact identifier
unii: 059QF0KO0R
Sterile WaterWATERA-S Medication Solutionsdba87371-31d2-47c2-ab83-89aabce4b1842024-01-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
MANNITOLMANNITOLHF Acquisition Co LLC, DBA HealthFirst999ce711-2d5b-0d7d-e053-2995a90a26892024-01-27Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
FamotidineFAMOTIDINEVKT Pharma Private Limited4e5db906-992f-476b-9d97-63a4c582bbdc2024-01-25WarningsExact identifier
unii: 5QZO15J2Z8
Pepcid CompleteFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE CHEWABLE TABLETLil' Drug Store Products, Inc.d08984b8-ce03-9e95-e053-2995a90ae6f02024-01-25WarningsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINELifestar Pharma LLC044a510f-33df-4484-8f07-d821f52b93762024-01-22Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
Acid ReducerFAMOTIDINEAllegiant Healthadc2721d-2ca7-4a47-bae1-be298fa1c1552024-01-16WarningsExact identifier
unii: 5QZO15J2Z8
Pepcid ACFAMOTIDINELil' Drug Store Products, Inc.14406cd8-468b-403d-9be2-43decd3042142024-01-09WarningsExact identifier
unii: 5QZO15J2Z8

Reported adverse events (FAERS/openFDA)#

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