vardenafil hydrochloride

Generic: vardenafil hydrochloride

Labeler: lannett company, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name vardenafil hydrochloride
Generic Name vardenafil hydrochloride
Labeler lannett company, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

vardenafil hydrochloride 5 mg/1

Manufacturer
Lannett Company, Inc.

Identifiers & Regulatory

Product NDC 0527-2801
Product ID 0527-2801_0a6ac33c-4a1f-4d07-b60e-453bb7111c9f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209057
Listing Expiration 2026-12-31
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 05272801
Hyphenated Format 0527-2801

Supplemental Identifiers

RxCUI
349478 349479 349480 402273
UPC
0305272802322
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 ANDA209057 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (0527-2801-32)
source: ndc

Packages (1)

0527-2801-32 30 TABLET in 1 BOTTLE (0527-2801-32)

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": "0a6ac33c-4a1f-4d07-b60e-453bb7111c9f", "openfda": {"upc": ["0305272802322"], "unii": ["5M8S2CU0TS"], "rxcui": ["349478", "349479", "349480", "402273"], "spl_set_id": ["2782efed-6198-47b9-81ac-3e255e2ab7f6"], "manufacturer_name": ["Lannett Company, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (0527-2801-32)", "package_ndc": "0527-2801-32", "marketing_start_date": "20181101"}], "brand_name": "Vardenafil Hydrochloride", "product_id": "0527-2801_0a6ac33c-4a1f-4d07-b60e-453bb7111c9f", "dosage_form": "TABLET", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "0527-2801", "generic_name": "Vardenafil Hydrochloride", "labeler_name": "Lannett Company, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Vardenafil Hydrochloride", "active_ingredients": [{"name": "VARDENAFIL HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA209057", "marketing_category": "ANDA", "marketing_start_date": "20181101", "listing_expiration_date": "20261231"}