vardenafil

Generic: vardenafil

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

Drug Facts

Product Profile

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

vardenafil hydrochloride trihydrate 10 mg/1

Manufacturer
Alembic Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 62332-235
Product ID 62332-235_33bb2a69-79e4-49bb-9388-97367b428639
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 62332235
Hyphenated Format 62332-235

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 BLISTER PACK in 1 CARTON (62332-235-04) / 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
source: ndc

Packages (1)

62332-235-04 4 BLISTER PACK in 1 CARTON (62332-235-04) / 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

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": "33bb2a69-79e4-49bb-9388-97367b428639", "openfda": {"unii": ["5M8S2CU0TS"], "rxcui": ["996179"], "spl_set_id": ["0ce4eb7b-fa50-441d-ae71-eb33dca27926"], "manufacturer_name": ["Alembic Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 BLISTER PACK in 1 CARTON (62332-235-04)  / 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK", "package_ndc": "62332-235-04", "marketing_start_date": "20181120"}], "brand_name": "Vardenafil", "product_id": "62332-235_33bb2a69-79e4-49bb-9388-97367b428639", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "62332-235", "generic_name": "Vardenafil", "labeler_name": "Alembic Pharmaceuticals Inc.", "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"}