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
2538995d-2df6-4c87-978a-5513c670b60f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 1, 2019
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
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 Code63187-813
Application NumberANDA203814
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sildenafil
Product Specifications
Route of AdministrationORAL
Effective DateDecember 1, 2018
FDA Product Classification
INGREDIENTS (8)
SILDENAFIL CITRATEActive
Quantity: 20 mg in 1 1
Code: BW9B0ZE037
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT