Famotidine
These highlights do not include all the information needed to use FAMOTIDINE TABLETS safely and effectively. See full prescribing information for FAMOTIDINE TABLETS. FAMOTIDINE tablets, for oral use Initial U.S. Approval: 1986
Approved
Approval ID
3e6d167f-91e4-4122-911d-d3da66386f44
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 10, 2022
Manufacturers
FDA
Major Pharmaceuticals
DUNS: 191427277
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 Code0904-7193
Application NumberANDA075718
Product Classification
M
Marketing Category
C73584
G
Generic Name
Famotidine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 10, 2022
FDA Product Classification
INGREDIENTS (10)
FamotidineActive
Quantity: 20 mg in 1 1
Code: 5QZO15J2Z8
Classification: ACTIB
Ferric Oxide YellowInactive
Code: EX438O2MRT
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Polyethylene Glycol 400Inactive
Code: B697894SGQ
Classification: IACT
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT