Sildenafil

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

Taro Pharmaceuticals U.S.A. Inc.

DUNS Number

600072078

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

51672-4231

Application Number

ANDA215522

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 12, 2023

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSLClass: IACT

SODIUM BENZOATEInactive

Code: OJ245FE5EUClass: IACT

SUCRALOSEInactive

Code: 96K6UQ3ZD4Class: IACT

SORBITOLInactive

Code: 506T60A25RClass: IACT

Code: BW9B0ZE037Class: ACTIMQuantity: 10 mg in 1 mL

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

XANTHAN GUMInactive

Code: TTV12P4NEEClass: IACT

TRISODIUM CITRATE DIHYDRATEInactive

Code: B22547B95KClass: IACT