sildenafil

Generic: sildenafil citrate

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name sildenafil
Generic Name sildenafil citrate
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sildenafil citrate 20 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 43353-345
Product ID 43353-345_c1c88939-6766-4d48-bf65-c0662f1472e4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021845
Listing Expiration 2026-12-31
Marketing Start 2012-09-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43353345
Hyphenated Format 43353-345

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 citrate (source: ndc)
Application Number NDA021845 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 10 TABLET, FILM COATED in 1 BOTTLE (43353-345-10)
  • 20 TABLET, FILM COATED in 1 BOTTLE (43353-345-20)
  • 60 TABLET, FILM COATED in 1 BOTTLE (43353-345-53)
source: ndc

Packages (3)

43353-345-10 10 TABLET, FILM COATED in 1 BOTTLE (43353-345-10) 43353-345-20 20 TABLET, FILM COATED in 1 BOTTLE (43353-345-20) 43353-345-53 60 TABLET, FILM COATED in 1 BOTTLE (43353-345-53)

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": "c1c88939-6766-4d48-bf65-c0662f1472e4", "openfda": {"unii": ["BW9B0ZE037"], "rxcui": ["577033"], "spl_set_id": ["761f9606-2583-439a-a29e-736008340a9e"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE (43353-345-10)", "package_ndc": "43353-345-10", "marketing_start_date": "20170703"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (43353-345-20)", "package_ndc": "43353-345-20", "marketing_start_date": "20170703"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (43353-345-53)", "package_ndc": "43353-345-53", "marketing_start_date": "20170703"}], "brand_name": "Sildenafil", "product_id": "43353-345_c1c88939-6766-4d48-bf65-c0662f1472e4", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "43353-345", "generic_name": "sildenafil citrate", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sildenafil", "active_ingredients": [{"name": "SILDENAFIL CITRATE", "strength": "20 mg/1"}], "application_number": "NDA021845", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20120927", "listing_expiration_date": "20261231"}