vardenafil hydrochloride

Generic: vardenafil hydrochloride

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name vardenafil hydrochloride
Generic Name vardenafil hydrochloride
Labeler chartwell rx, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

vardenafil hydrochloride 2.5 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-864
Product ID 62135-864_459d49f5-7be3-8f85-e063-6294a90a2064
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209057
Listing Expiration 2026-12-31
Marketing Start 2018-10-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135864
Hyphenated Format 62135-864

Supplemental Identifiers

RxCUI
402273
UPC
0362135864309
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
  • 2.5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (62135-864-30)
source: ndc

Packages (1)

62135-864-30 30 TABLET in 1 BOTTLE (62135-864-30)

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": "459d49f5-7be3-8f85-e063-6294a90a2064", "openfda": {"upc": ["0362135864309"], "unii": ["5M8S2CU0TS"], "rxcui": ["402273"], "spl_set_id": ["57a0c163-a5e8-4c6e-a4ea-114cb2668407"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (62135-864-30)", "package_ndc": "62135-864-30", "marketing_start_date": "20240226"}], "brand_name": "Vardenafil Hydrochloride", "product_id": "62135-864_459d49f5-7be3-8f85-e063-6294a90a2064", "dosage_form": "TABLET", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "62135-864", "generic_name": "Vardenafil Hydrochloride", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Vardenafil Hydrochloride", "active_ingredients": [{"name": "VARDENAFIL HYDROCHLORIDE", "strength": "2.5 mg/1"}], "application_number": "ANDA209057", "marketing_category": "ANDA", "marketing_start_date": "20181031", "listing_expiration_date": "20261231"}