vardenafil

Generic: vardenafil

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name vardenafil
Generic Name vardenafil
Labeler zydus lifesciences limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

vardenafil hydrochloride trihydrate 5 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1048
Product ID 70771-1048_4fb9ca6c-4610-42f9-87f0-224d76c542f2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208960
Listing Expiration 2027-12-31
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 707711048
Hyphenated Format 70771-1048

Supplemental Identifiers

RxCUI
349478 349479 349480 402273
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 (source: ndc)
Generic Name vardenafil (source: ndc)
Application Number ANDA208960 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (70771-1048-1)
  • 30 TABLET, FILM COATED in 1 BOTTLE (70771-1048-3)
  • 90 TABLET, FILM COATED in 1 BOTTLE (70771-1048-9)
source: ndc

Packages (3)

70771-1048-1 100 TABLET, FILM COATED in 1 BOTTLE (70771-1048-1) 70771-1048-3 30 TABLET, FILM COATED in 1 BOTTLE (70771-1048-3) 70771-1048-9 90 TABLET, FILM COATED in 1 BOTTLE (70771-1048-9)

Ingredients (1)

vardenafil hydrochloride trihydrate (5 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": "4fb9ca6c-4610-42f9-87f0-224d76c542f2", "openfda": {"unii": ["5M8S2CU0TS"], "rxcui": ["349478", "349479", "349480", "402273"], "spl_set_id": ["8ea14f7e-44a0-4d9c-968a-87b97ca12f09"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (70771-1048-1)", "package_ndc": "70771-1048-1", "marketing_start_date": "20181101"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (70771-1048-3)", "package_ndc": "70771-1048-3", "marketing_start_date": "20181101"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (70771-1048-9)", "package_ndc": "70771-1048-9", "marketing_start_date": "20181101"}], "brand_name": "VARDENAFIL", "product_id": "70771-1048_4fb9ca6c-4610-42f9-87f0-224d76c542f2", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "70771-1048", "generic_name": "VARDENAFIL", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VARDENAFIL", "active_ingredients": [{"name": "VARDENAFIL HYDROCHLORIDE TRIHYDRATE", "strength": "5 mg/1"}], "application_number": "ANDA208960", "marketing_category": "ANDA", "marketing_start_date": "20181101", "listing_expiration_date": "20271231"}