vardenafil hydrochloride

Generic: vardenafil hydrochloride

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name vardenafil hydrochloride
Generic Name vardenafil hydrochloride
Labeler avkare
Dosage Form TABLET
Routes
ORAL
Active Ingredients

vardenafil hydrochloride 5 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-826
Product ID 42291-826_3b038d71-adaa-fc9a-e063-6294a90abe6a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209057
Listing Expiration 2026-12-31
Marketing Start 2025-07-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42291826
Hyphenated Format 42291-826

Supplemental Identifiers

RxCUI
349478
UPC
0342291847309
UNII
5M8S2CU0TS

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 vardenafil hydrochloride (source: ndc)
Generic Name vardenafil hydrochloride (source: ndc)
Application Number ANDA209057 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (42291-826-30)
source: ndc

Packages (1)

42291-826-30 30 TABLET in 1 BOTTLE (42291-826-30)

Ingredients (1)

vardenafil hydrochloride (5 mg/1)

Linked Drug Pages (1)

Vardenafil Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3b038d71-adaa-fc9a-e063-6294a90abe6a", "openfda": {"upc": ["0342291847309"], "unii": ["5M8S2CU0TS"], "rxcui": ["349478"], "spl_set_id": ["3b03952b-d404-09cd-e063-6294a90a8b2c"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (42291-826-30)", "package_ndc": "42291-826-30", "marketing_start_date": "20250728"}], "brand_name": "Vardenafil Hydrochloride", "product_id": "42291-826_3b038d71-adaa-fc9a-e063-6294a90abe6a", "dosage_form": "TABLET", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "42291-826", "generic_name": "Vardenafil Hydrochloride", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Vardenafil Hydrochloride", "active_ingredients": [{"name": "VARDENAFIL HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA209057", "marketing_category": "ANDA", "marketing_start_date": "20250728", "listing_expiration_date": "20261231"}