vardenafil hydrochloride

Generic: vardenafil hydrochloride

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

Drug Facts

Product Profile

Brand Name vardenafil hydrochloride
Generic Name vardenafil hydrochloride
Labeler alembic pharmaceuticals limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

vardenafil hydrochloride 2.5 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-236
Product ID 46708-236_f87ba545-36e3-4d7d-aa52-3976a44e1719
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214031
Listing Expiration 2026-12-31
Marketing Start 2020-08-05

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708236
Hyphenated Format 46708-236

Supplemental Identifiers

RxCUI
349478 349479 349480 402273
UPC
0346708236304 0346708238308 0346708239305 0346708237301
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 ANDA214031 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (46708-236-30)
  • 100 TABLET, FILM COATED in 1 BOTTLE (46708-236-31)
source: ndc

Packages (2)

46708-236-30 30 TABLET, FILM COATED in 1 BOTTLE (46708-236-30) 46708-236-31 100 TABLET, FILM COATED in 1 BOTTLE (46708-236-31)

Ingredients (1)

vardenafil hydrochloride (2.5 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": "f87ba545-36e3-4d7d-aa52-3976a44e1719", "openfda": {"upc": ["0346708236304", "0346708238308", "0346708239305", "0346708237301"], "unii": ["5M8S2CU0TS"], "rxcui": ["349478", "349479", "349480", "402273"], "spl_set_id": ["9b8da728-8f52-4c1f-9f0c-4bd9736e912f"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (46708-236-30)", "package_ndc": "46708-236-30", "marketing_start_date": "20200805"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (46708-236-31)", "package_ndc": "46708-236-31", "marketing_start_date": "20200805"}], "brand_name": "VARDENAFIL HYDROCHLORIDE", "product_id": "46708-236_f87ba545-36e3-4d7d-aa52-3976a44e1719", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "46708-236", "generic_name": "VARDENAFIL HYDROCHLORIDE", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VARDENAFIL HYDROCHLORIDE", "active_ingredients": [{"name": "VARDENAFIL HYDROCHLORIDE", "strength": "2.5 mg/1"}], "application_number": "ANDA214031", "marketing_category": "ANDA", "marketing_start_date": "20200805", "listing_expiration_date": "20261231"}