sildenafil

Generic: sildenafil

Labeler: quallent pharmaceuticals health llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sildenafil
Generic Name sildenafil
Labeler quallent pharmaceuticals health llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sildenafil citrate 20 mg/1

Manufacturer
Quallent Pharmaceuticals Health LLC

Identifiers & Regulatory

Product NDC 82009-094
Product ID 82009-094_3548d614-f7d1-4628-88b8-c5cae1178df0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210394
Listing Expiration 2026-12-31
Marketing Start 2023-07-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82009094
Hyphenated Format 82009-094

Supplemental Identifiers

RxCUI
577033
UPC
0382009094908
UNII
BW9B0ZE037

Packaging Origin

Original Packager
true

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 ANDA210394 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (82009-094-90)
source: ndc

Packages (1)

82009-094-90 90 TABLET in 1 BOTTLE (82009-094-90)

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": "3548d614-f7d1-4628-88b8-c5cae1178df0", "openfda": {"upc": ["0382009094908"], "unii": ["BW9B0ZE037"], "rxcui": ["577033"], "spl_set_id": ["333ca682-931f-4edb-95d6-2edbd87631cf"], "manufacturer_name": ["Quallent Pharmaceuticals Health LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (82009-094-90)", "package_ndc": "82009-094-90", "marketing_start_date": "20230719"}], "brand_name": "Sildenafil", "product_id": "82009-094_3548d614-f7d1-4628-88b8-c5cae1178df0", "dosage_form": "TABLET", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "82009-094", "generic_name": "Sildenafil", "labeler_name": "Quallent Pharmaceuticals Health LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sildenafil", "active_ingredients": [{"name": "SILDENAFIL CITRATE", "strength": "20 mg/1"}], "application_number": "ANDA210394", "marketing_category": "ANDA", "marketing_start_date": "20230719", "listing_expiration_date": "20261231"}