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
974abf58-f43c-4ead-b11d-daf98cc6934b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 5, 2024
Manufacturers
FDA
Graviti Pharmaceuticals Private Limited
DUNS: 650884781
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 Code69844-096
Application NumberANDA218181
Product Classification
M
Marketing Category
C73584
G
Generic Name
Famotidine
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 5, 2024
FDA Product Classification
INGREDIENTS (12)
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
FAMOTIDINEActive
Quantity: 40 mg in 1 1
Code: 5QZO15J2Z8
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
Famotidine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69844-095
Application NumberANDA218181
Product Classification
M
Marketing Category
C73584
G
Generic Name
Famotidine
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 5, 2024
FDA Product Classification
INGREDIENTS (14)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FAMOTIDINEActive
Quantity: 20 mg in 1 1
Code: 5QZO15J2Z8
Classification: ACTIB
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT