Famotidine
These highlights do not include all the information needed to use FAMOTIDINE TABLETS safely and effectively. See full prescribing information for FAMOTIDINE TABLETS. Initial U.S. Approval: 1986
Approved
Approval ID
a8b5c855-053d-4295-8f57-1a96a6ccaa92
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 24, 2023
Manufacturers
FDA
Carlsbad Technology, Inc
DUNS: 781047246
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Famotidine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61442-122
Application NumberANDA075805
Product Classification
M
Marketing Category
C73584
G
Generic Name
Famotidine
Product Specifications
Route of AdministrationORAL
Effective DateMarch 24, 2023
FDA Product Classification
INGREDIENTS (9)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FAMOTIDINEActive
Quantity: 40 mg in 1 1
Code: 5QZO15J2Z8
Classification: ACTIB
Famotidine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61442-121
Application NumberANDA075805
Product Classification
M
Marketing Category
C73584
G
Generic Name
Famotidine
Product Specifications
Route of AdministrationORAL
Effective DateMarch 24, 2023
FDA Product Classification
INGREDIENTS (9)
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FAMOTIDINEActive
Quantity: 20 mg in 1 1
Code: 5QZO15J2Z8
Classification: ACTIB