Sildenafil

Manufacturing Establishments1

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

Labeler

NuCare Pharmaceuticals,Inc.

DUNS Number

010632300

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

NDC Product Code

68071-2217

Application Number

ANDA203623

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 20, 2022

Ingredients

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive

Code: L11K75P92JClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

Code: BW9B0ZE037Class: ACTIMQuantity: 20 mg in 1 1

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TRIACETINInactive

Code: XHX3C3X673Class: IACT