FAMOTIDINE
FAMOTIDINE
Approved
Approval ID
b1b82d2a-cdb5-3e22-e053-2995a90a917d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 29, 2022
Manufacturers
FDA
direct rx
DUNS: 079254320
Products 1
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 Code72189-141
Application NumberANDA078916
Product Classification
M
Marketing Category
C73584
G
Generic Name
FAMOTIDINE
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 29, 2022
FDA Product Classification
INGREDIENTS (11)
FAMOTIDINEActive
Quantity: 20 mg in 1 1
Code: 5QZO15J2Z8
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT