vardenafil hydrochloride

Generic: vardenafil hydrochloride

Labeler: teva pharmaceuticals usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name vardenafil hydrochloride
Generic Name vardenafil hydrochloride
Labeler teva pharmaceuticals usa, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

vardenafil hydrochloride 5 mg/1

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0093-7653
Product ID 0093-7653_51f4534a-5b11-490a-9e0b-ac681150967f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091347
Listing Expiration 2026-12-31
Marketing Start 2019-01-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00937653
Hyphenated Format 0093-7653

Supplemental Identifiers

RxCUI
349478 349479 349480 402273
UPC
0300937654568 0300937653561
UNII
5M8S2CU0TS

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 vardenafil hydrochloride (source: ndc)
Generic Name vardenafil hydrochloride (source: ndc)
Application Number ANDA091347 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (0093-7653-56)
source: ndc

Packages (1)

0093-7653-56 30 TABLET, FILM COATED in 1 BOTTLE (0093-7653-56)

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": "51f4534a-5b11-490a-9e0b-ac681150967f", "openfda": {"upc": ["0300937654568", "0300937653561"], "unii": ["5M8S2CU0TS"], "rxcui": ["349478", "349479", "349480", "402273"], "spl_set_id": ["e593ab58-70a4-4095-8091-16a4b6d49e4d"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (0093-7653-56)", "package_ndc": "0093-7653-56", "marketing_start_date": "20190103"}], "brand_name": "Vardenafil Hydrochloride", "product_id": "0093-7653_51f4534a-5b11-490a-9e0b-ac681150967f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "0093-7653", "generic_name": "Vardenafil Hydrochloride", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Vardenafil Hydrochloride", "active_ingredients": [{"name": "VARDENAFIL HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA091347", "marketing_category": "ANDA", "marketing_start_date": "20190103", "listing_expiration_date": "20261231"}