vardenafil hydrochloride

Generic: vardenafil hydrochloride

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

Drug Facts

Product Profile

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

vardenafil hydrochloride 20 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-508
Product ID 71610-508_56a14d26-0c09-4a32-bec0-d4fba1003548
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209057
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 71610508
Hyphenated Format 71610-508

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

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 2 TABLET in 1 BOTTLE (71610-508-02)
  • 4 TABLET in 1 BOTTLE (71610-508-04)
  • 12 TABLET in 1 BOTTLE (71610-508-12)
source: ndc

Packages (3)

71610-508-02 2 TABLET in 1 BOTTLE (71610-508-02) 71610-508-04 4 TABLET in 1 BOTTLE (71610-508-04) 71610-508-12 12 TABLET in 1 BOTTLE (71610-508-12)

Ingredients (1)

vardenafil hydrochloride (20 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": "56a14d26-0c09-4a32-bec0-d4fba1003548", "openfda": {"unii": ["5M8S2CU0TS"], "rxcui": ["349480"], "spl_set_id": ["09366eb3-93e0-41d9-bf9a-24335ed3555f"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "2 TABLET in 1 BOTTLE (71610-508-02)", "package_ndc": "71610-508-02", "marketing_start_date": "20201221"}, {"sample": false, "description": "4 TABLET in 1 BOTTLE (71610-508-04)", "package_ndc": "71610-508-04", "marketing_start_date": "20201221"}, {"sample": false, "description": "12 TABLET in 1 BOTTLE (71610-508-12)", "package_ndc": "71610-508-12", "marketing_start_date": "20201221"}], "brand_name": "Vardenafil Hydrochloride", "product_id": "71610-508_56a14d26-0c09-4a32-bec0-d4fba1003548", "dosage_form": "TABLET", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "71610-508", "generic_name": "Vardenafil Hydrochloride", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Vardenafil Hydrochloride", "active_ingredients": [{"name": "VARDENAFIL HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA209057", "marketing_category": "ANDA", "marketing_start_date": "20181101", "listing_expiration_date": "20261231"}