sildenafil citrate

Generic: sildenafil

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

Drug Facts

Product Profile

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

sildenafil citrate 100 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-565
Product ID 76420-565_fb50d332-1618-2b63-e053-6394a90ad585
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206401
Listing Expiration 2026-12-31
Marketing Start 2018-10-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420565
Hyphenated Format 76420-565

Supplemental Identifiers

RxCUI
312950 314228 314229
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 citrate (source: ndc)
Generic Name sildenafil (source: ndc)
Application Number ANDA206401 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (76420-565-01)
  • 30 TABLET, FILM COATED in 1 BOTTLE (76420-565-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (76420-565-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE (76420-565-90)
source: ndc

Packages (4)

76420-565-01 100 TABLET, FILM COATED in 1 BOTTLE (76420-565-01) 76420-565-30 30 TABLET, FILM COATED in 1 BOTTLE (76420-565-30) 76420-565-60 60 TABLET, FILM COATED in 1 BOTTLE (76420-565-60) 76420-565-90 90 TABLET, FILM COATED in 1 BOTTLE (76420-565-90)

Ingredients (1)

sildenafil citrate (100 mg/1)

Linked Drug Pages (1)

Sildenafil Citrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "fb50d332-1618-2b63-e053-6394a90ad585", "openfda": {"unii": ["BW9B0ZE037"], "rxcui": ["312950", "314228", "314229"], "spl_set_id": ["0500a861-359f-4e12-beb5-0cac8cd6ae1c"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (76420-565-01)", "package_ndc": "76420-565-01", "marketing_start_date": "20230510"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (76420-565-30)", "package_ndc": "76420-565-30", "marketing_start_date": "20230510"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (76420-565-60)", "package_ndc": "76420-565-60", "marketing_start_date": "20230510"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (76420-565-90)", "package_ndc": "76420-565-90", "marketing_start_date": "20230510"}], "brand_name": "Sildenafil Citrate", "product_id": "76420-565_fb50d332-1618-2b63-e053-6394a90ad585", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "76420-565", "generic_name": "Sildenafil", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sildenafil Citrate", "active_ingredients": [{"name": "SILDENAFIL CITRATE", "strength": "100 mg/1"}], "application_number": "ANDA206401", "marketing_category": "ANDA", "marketing_start_date": "20181012", "listing_expiration_date": "20261231"}