tadalafil

Generic: tadalafil

Labeler: vkt pharma private limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tadalafil
Generic Name tadalafil
Labeler vkt pharma private limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

tadalafil 10 mg/1

Manufacturer
VKT Pharma Private Limited

Identifiers & Regulatory

Product NDC 71821-008
Product ID 71821-008_d0fb5849-3fc9-11d3-e053-2995a90a5bbc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215556
Listing Expiration 2026-12-31
Marketing Start 2021-11-04

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 71821008
Hyphenated Format 71821-008

Supplemental Identifiers

RxCUI
402019 403957 484814 757707
UPC
0371821009016 0371821006015 0371821007029 0371821007012
UNII
742SXX0ICT
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 tadalafil (source: ndc)
Generic Name tadalafil (source: ndc)
Application Number ANDA215556 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (71821-008-01)
source: ndc

Packages (1)

71821-008-01 30 TABLET, FILM COATED in 1 BOTTLE (71821-008-01)

Ingredients (1)

tadalafil (10 mg/1)

Linked Drug Pages (1)

tadalafil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d0fb5849-3fc9-11d3-e053-2995a90a5bbc", "openfda": {"nui": ["N0000175599", "N0000020026"], "upc": ["0371821009016", "0371821006015", "0371821007029", "0371821007012"], "unii": ["742SXX0ICT"], "rxcui": ["402019", "403957", "484814", "757707"], "spl_set_id": ["b4d9851c-5c06-4532-bd82-16d92b60c28f"], "pharm_class_epc": ["Phosphodiesterase 5 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 5 Inhibitors [MoA]"], "manufacturer_name": ["VKT Pharma Private Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71821-008-01)", "package_ndc": "71821-008-01", "marketing_start_date": "20211104"}], "brand_name": "tadalafil", "product_id": "71821-008_d0fb5849-3fc9-11d3-e053-2995a90a5bbc", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "71821-008", "generic_name": "Tadalafil", "labeler_name": "VKT Pharma Private Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "tadalafil", "active_ingredients": [{"name": "TADALAFIL", "strength": "10 mg/1"}], "application_number": "ANDA215556", "marketing_category": "ANDA", "marketing_start_date": "20211104", "listing_expiration_date": "20261231"}