sildenafil citrate

Generic: sildenafil

Labeler: advanced rx of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sildenafil citrate
Generic Name sildenafil
Labeler advanced rx of tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sildenafil citrate 100 mg/1

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0410
Product ID 80425-0410_1ceb66c5-0d49-0ab1-e063-6294a90a83d4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206401
Listing Expiration 2026-12-31
Marketing Start 2024-07-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 804250410
Hyphenated Format 80425-0410

Supplemental Identifiers

RxCUI
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
  • 6 TABLET, FILM COATED in 1 BOTTLE (80425-0410-1)
  • 12 TABLET, FILM COATED in 1 BOTTLE (80425-0410-2)
  • 30 TABLET, FILM COATED in 1 BOTTLE (80425-0410-3)
source: ndc

Packages (3)

80425-0410-1 6 TABLET, FILM COATED in 1 BOTTLE (80425-0410-1) 80425-0410-2 12 TABLET, FILM COATED in 1 BOTTLE (80425-0410-2) 80425-0410-3 30 TABLET, FILM COATED in 1 BOTTLE (80425-0410-3)

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": "1ceb66c5-0d49-0ab1-e063-6294a90a83d4", "openfda": {"unii": ["BW9B0ZE037"], "rxcui": ["314229"], "spl_set_id": ["1ceb575b-2687-0456-e063-6394a90aa88a"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "6 TABLET, FILM COATED in 1 BOTTLE (80425-0410-1)", "package_ndc": "80425-0410-1", "marketing_start_date": "20240710"}, {"sample": false, "description": "12 TABLET, FILM COATED in 1 BOTTLE (80425-0410-2)", "package_ndc": "80425-0410-2", "marketing_start_date": "20240710"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (80425-0410-3)", "package_ndc": "80425-0410-3", "marketing_start_date": "20240710"}], "brand_name": "Sildenafil Citrate", "product_id": "80425-0410_1ceb66c5-0d49-0ab1-e063-6294a90a83d4", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "80425-0410", "generic_name": "Sildenafil", "labeler_name": "Advanced Rx of Tennessee, LLC", "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": "20240710", "listing_expiration_date": "20261231"}