Sildenafil
These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998
Approved
Approval ID
fa14cb6b-0fa8-0ba0-e053-6294a90afae3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 24, 2023
Manufacturers
FDA
Northwind Pharmaceuticals, LLC
DUNS: 036986393
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sildenafil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51655-172
Application NumberANDA202025
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sildenafil
Product Specifications
Route of AdministrationORAL
Effective DateApril 24, 2023
FDA Product Classification
INGREDIENTS (10)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CALCIUM PHOSPHATE, MONOBASIC, ANHYDROUSInactive
Code: 701EKV9RMN
Classification: IACT
SILDENAFIL CITRATEActive
Quantity: 20 mg in 1 1
Code: BW9B0ZE037
Classification: ACTIM