vardenafil hydrochloride

Generic: vardenafil hydrochloride

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

Drug Facts

Product Profile

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

vardenafil 2.5 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-151
Product ID 33342-151_b02d220c-5dd4-4557-880a-7d4c0d8927b9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204632
Listing Expiration 2026-12-31
Marketing Start 2019-10-24

Pharmacologic Class

Established (EPC)
phosphodiesterase 5 inhibitor [epc]
Mechanism of Action
phosphodiesterase 5 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 33342151
Hyphenated Format 33342-151

Supplemental Identifiers

RxCUI
349478 349479 349480 402273
UPC
0333342154071 0068100003338
UNII
UCE6F4125H
NUI
N0000175599 N0000020026

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 ANDA204632 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (33342-151-07)
  • 100 TABLET in 1 BOTTLE (33342-151-11)
  • 10 BLISTER PACK in 1 CARTON (33342-151-12) / 10 TABLET in 1 BLISTER PACK
source: ndc

Packages (3)

33342-151-07 30 TABLET in 1 BOTTLE (33342-151-07) 33342-151-11 100 TABLET in 1 BOTTLE (33342-151-11) 33342-151-12 10 BLISTER PACK in 1 CARTON (33342-151-12) / 10 TABLET in 1 BLISTER PACK

Ingredients (1)

vardenafil (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": "b02d220c-5dd4-4557-880a-7d4c0d8927b9", "openfda": {"nui": ["N0000175599", "N0000020026"], "upc": ["0333342154071", "0068100003338"], "unii": ["UCE6F4125H"], "rxcui": ["349478", "349479", "349480", "402273"], "spl_set_id": ["a38de6e1-21ca-4ebe-a3c7-6f849cf8b675"], "pharm_class_epc": ["Phosphodiesterase 5 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 5 Inhibitors [MoA]"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (33342-151-07)", "package_ndc": "33342-151-07", "marketing_start_date": "20191024"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (33342-151-11)", "package_ndc": "33342-151-11", "marketing_start_date": "20191024"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (33342-151-12)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "33342-151-12", "marketing_start_date": "20191024"}], "brand_name": "Vardenafil Hydrochloride", "product_id": "33342-151_b02d220c-5dd4-4557-880a-7d4c0d8927b9", "dosage_form": "TABLET", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "33342-151", "generic_name": "Vardenafil Hydrochloride", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Vardenafil Hydrochloride", "active_ingredients": [{"name": "VARDENAFIL", "strength": "2.5 mg/1"}], "application_number": "ANDA204632", "marketing_category": "ANDA", "marketing_start_date": "20191024", "listing_expiration_date": "20261231"}