sildenafil citrate

Generic: sildenafil

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

Drug Facts

Product Profile

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

sildenafil citrate 100 mg/1

Manufacturer
Quallent Pharmaceuticals Health LLC

Identifiers & Regulatory

Product NDC 82009-093
Product ID 82009-093_853230e4-4f33-420e-bd3c-d5b45f4e0689
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206401
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 82009093
Hyphenated Format 82009-093

Supplemental Identifiers

RxCUI
314229
UPC
0382009093017
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 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 (82009-093-01)
source: ndc

Packages (1)

82009-093-01 100 TABLET, FILM COATED in 1 BOTTLE (82009-093-01)

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": "853230e4-4f33-420e-bd3c-d5b45f4e0689", "openfda": {"upc": ["0382009093017"], "unii": ["BW9B0ZE037"], "rxcui": ["314229"], "spl_set_id": ["41b67fd2-3d9a-49d6-88b8-285044b98dc1"], "manufacturer_name": ["Quallent Pharmaceuticals Health LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (82009-093-01)", "package_ndc": "82009-093-01", "marketing_start_date": "20230719"}], "brand_name": "Sildenafil Citrate", "product_id": "82009-093_853230e4-4f33-420e-bd3c-d5b45f4e0689", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "82009-093", "generic_name": "Sildenafil", "labeler_name": "Quallent Pharmaceuticals Health 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": "20230719", "listing_expiration_date": "20261231"}