vardenafil

Generic: vardenafil

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name vardenafil
Generic Name vardenafil
Labeler alembic pharmaceuticals limited
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

vardenafil hydrochloride trihydrate 10 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-235
Product ID 46708-235_2ca8929b-0b62-4302-9ab4-60ad3768e803
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208324
Listing Expiration 2026-12-31
Marketing Start 2018-11-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708235
Hyphenated Format 46708-235

Supplemental Identifiers

RxCUI
996179
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 ANDA208324 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (46708-235-04)
source: ndc

Packages (1)

46708-235-04 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (46708-235-04)

Ingredients (1)

vardenafil hydrochloride trihydrate (10 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": "2ca8929b-0b62-4302-9ab4-60ad3768e803", "openfda": {"unii": ["5M8S2CU0TS"], "rxcui": ["996179"], "spl_set_id": ["dce0b31b-4522-4cb4-9dba-3aea2b2bb082"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (46708-235-04)", "package_ndc": "46708-235-04", "marketing_start_date": "20181120"}], "brand_name": "Vardenafil", "product_id": "46708-235_2ca8929b-0b62-4302-9ab4-60ad3768e803", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "46708-235", "generic_name": "Vardenafil", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Vardenafil", "active_ingredients": [{"name": "VARDENAFIL HYDROCHLORIDE TRIHYDRATE", "strength": "10 mg/1"}], "application_number": "ANDA208324", "marketing_category": "ANDA", "marketing_start_date": "20181120", "listing_expiration_date": "20261231"}