vardenafil

Generic: vardenafil

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

Drug Facts

Product Profile

Brand Name vardenafil
Generic Name vardenafil
Labeler macleods pharmaceuticals limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

vardenafil hydrochloride trihydrate 11.85 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-203
Product ID 33342-203_695d5a7e-546f-4e86-8edc-3c32e1d3bb19
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205988
Listing Expiration 2026-12-31
Marketing Start 2018-10-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 33342203
Hyphenated Format 33342-203

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 ANDA205988 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 11.85 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (33342-203-37) / 4 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

33342-203-37 1 BLISTER PACK in 1 CARTON (33342-203-37) / 4 TABLET in 1 BLISTER PACK

Ingredients (1)

vardenafil hydrochloride trihydrate (11.85 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": "695d5a7e-546f-4e86-8edc-3c32e1d3bb19", "openfda": {"unii": ["5M8S2CU0TS"], "rxcui": ["996179"], "spl_set_id": ["0ad213e0-d18a-4e67-a405-df95322eaa52"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (33342-203-37)  / 4 TABLET in 1 BLISTER PACK", "package_ndc": "33342-203-37", "marketing_start_date": "20181026"}], "brand_name": "Vardenafil", "product_id": "33342-203_695d5a7e-546f-4e86-8edc-3c32e1d3bb19", "dosage_form": "TABLET", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "33342-203", "generic_name": "Vardenafil", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Vardenafil", "active_ingredients": [{"name": "VARDENAFIL HYDROCHLORIDE TRIHYDRATE", "strength": "11.85 mg/1"}], "application_number": "ANDA205988", "marketing_category": "ANDA", "marketing_start_date": "20181026", "listing_expiration_date": "20261231"}