sildenafil

Generic: sildenafil

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sildenafil
Generic Name sildenafil
Labeler asclemed usa, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sildenafil citrate 20 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-061
Product ID 76420-061_e785ec65-b5e8-693c-e053-2995a90aa9e7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203814
Listing Expiration 2026-12-31
Marketing Start 2014-01-03

Pharmacologic Class

Classes
phosphodiesterase 5 inhibitor [epc] phosphodiesterase 5 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420061
Hyphenated Format 76420-061

Supplemental Identifiers

RxCUI
577033
UNII
BW9B0ZE037

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name sildenafil (source: ndc)
Generic Name sildenafil (source: ndc)
Application Number ANDA203814 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (76420-061-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (76420-061-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE (76420-061-90)
source: ndc

Packages (3)

76420-061-30 30 TABLET, FILM COATED in 1 BOTTLE (76420-061-30) 76420-061-60 60 TABLET, FILM COATED in 1 BOTTLE (76420-061-60) 76420-061-90 90 TABLET, FILM COATED in 1 BOTTLE (76420-061-90)

Ingredients (1)

sildenafil citrate (20 mg/1)

Linked Drug Pages (1)

Sildenafil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e785ec65-b5e8-693c-e053-2995a90aa9e7", "openfda": {"unii": ["BW9B0ZE037"], "rxcui": ["577033"], "spl_set_id": ["06571775-b651-4e23-a35b-88392aae7e13"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (76420-061-30)", "package_ndc": "76420-061-30", "marketing_start_date": "20191210"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (76420-061-60)", "package_ndc": "76420-061-60", "marketing_start_date": "20220831"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (76420-061-90)", "package_ndc": "76420-061-90", "marketing_start_date": "20191210"}], "brand_name": "Sildenafil", "product_id": "76420-061_e785ec65-b5e8-693c-e053-2995a90aa9e7", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "76420-061", "generic_name": "Sildenafil", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sildenafil", "active_ingredients": [{"name": "SILDENAFIL CITRATE", "strength": "20 mg/1"}], "application_number": "ANDA203814", "marketing_category": "ANDA", "marketing_start_date": "20140103", "listing_expiration_date": "20261231"}