vardenafil

Generic: vardenafil

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

Drug Facts

Product Profile

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

vardenafil hydrochloride trihydrate 20 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-477
Product ID 71610-477_9d2796f2-b596-4588-96c8-f99407d3e671
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208960
Listing Expiration 2026-12-31
Marketing Start 2018-11-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610477
Hyphenated Format 71610-477

Supplemental Identifiers

RxCUI
349480
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 (source: ndc)
Generic Name vardenafil (source: ndc)
Application Number ANDA208960 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 2 TABLET, FILM COATED in 1 BOTTLE (71610-477-02)
  • 4 TABLET, FILM COATED in 1 BOTTLE (71610-477-04)
  • 6 TABLET, FILM COATED in 1 BOTTLE (71610-477-06)
  • 12 TABLET, FILM COATED in 1 BOTTLE (71610-477-12)
source: ndc

Packages (4)

71610-477-02 2 TABLET, FILM COATED in 1 BOTTLE (71610-477-02) 71610-477-04 4 TABLET, FILM COATED in 1 BOTTLE (71610-477-04) 71610-477-06 6 TABLET, FILM COATED in 1 BOTTLE (71610-477-06) 71610-477-12 12 TABLET, FILM COATED in 1 BOTTLE (71610-477-12)

Ingredients (1)

vardenafil hydrochloride trihydrate (20 mg/1)

Linked Drug Pages (1)

VARDENAFIL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9d2796f2-b596-4588-96c8-f99407d3e671", "openfda": {"unii": ["5M8S2CU0TS"], "rxcui": ["349480"], "spl_set_id": ["c70a9c8e-46b0-489d-bbda-2d7fca4b629f"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "2 TABLET, FILM COATED in 1 BOTTLE (71610-477-02)", "package_ndc": "71610-477-02", "marketing_start_date": "20201105"}, {"sample": false, "description": "4 TABLET, FILM COATED in 1 BOTTLE (71610-477-04)", "package_ndc": "71610-477-04", "marketing_start_date": "20201023"}, {"sample": false, "description": "6 TABLET, FILM COATED in 1 BOTTLE (71610-477-06)", "package_ndc": "71610-477-06", "marketing_start_date": "20210503"}, {"sample": false, "description": "12 TABLET, FILM COATED in 1 BOTTLE (71610-477-12)", "package_ndc": "71610-477-12", "marketing_start_date": "20210407"}], "brand_name": "VARDENAFIL", "product_id": "71610-477_9d2796f2-b596-4588-96c8-f99407d3e671", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "71610-477", "generic_name": "VARDENAFIL", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VARDENAFIL", "active_ingredients": [{"name": "VARDENAFIL HYDROCHLORIDE TRIHYDRATE", "strength": "20 mg/1"}], "application_number": "ANDA208960", "marketing_category": "ANDA", "marketing_start_date": "20181101", "listing_expiration_date": "20261231"}