Famotidine
Famotidine 20mg
Approved
Approval ID
886287cf-a6f7-6770-e053-2a95a90a21bb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 13, 2021
Manufacturers
FDA
RedPharm Drug, Inc.
DUNS: 828374897
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 Code67296-1121
Application NumberANDA075511
Product Classification
M
Marketing Category
C73584
G
Generic Name
Famotidine
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 13, 2021
FDA Product Classification
INGREDIENTS (15)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLYETHYLENE GLYCOL 3000Inactive
Code: SA1B764746
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FAMOTIDINEActive
Quantity: 20 mg in 1 1
Code: 5QZO15J2Z8
Classification: ACTIB