tadalafil

Generic: tadalafil

Labeler: fourrts (india) laboratories private limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tadalafil
Generic Name tadalafil
Labeler fourrts (india) laboratories private limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

tadalafil 5 mg/1

Manufacturer
FOURRTS (INDIA) LABORATORIES PRIVATE LIMITED

Identifiers & Regulatory

Product NDC 82968-002
Product ID 82968-002_464c2d55-32ca-db41-e063-6294a90a9103
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217606
Listing Expiration 2026-12-31
Marketing Start 2024-08-21

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 82968002
Hyphenated Format 82968-002

Supplemental Identifiers

RxCUI
402019 403957 484814 757707
UPC
0382968002020 0382968003010 0382968001030 0382968005014 0382968002013
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 ANDA217606 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (82968-002-01)
  • 2 BLISTER PACK in 1 CARTON (82968-002-02) / 15 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (2)

82968-002-01 30 TABLET, FILM COATED in 1 BOTTLE (82968-002-01) 82968-002-02 2 BLISTER PACK in 1 CARTON (82968-002-02) / 15 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

tadalafil (5 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": "464c2d55-32ca-db41-e063-6294a90a9103", "openfda": {"nui": ["N0000175599", "N0000020026"], "upc": ["0382968002020", "0382968003010", "0382968001030", "0382968005014", "0382968002013"], "unii": ["742SXX0ICT"], "rxcui": ["402019", "403957", "484814", "757707"], "spl_set_id": ["0ea97208-5afc-4943-b35c-ea850203a794"], "pharm_class_epc": ["Phosphodiesterase 5 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 5 Inhibitors [MoA]"], "manufacturer_name": ["FOURRTS (INDIA) LABORATORIES PRIVATE LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (82968-002-01)", "package_ndc": "82968-002-01", "marketing_start_date": "20240821"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (82968-002-02)  / 15 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "82968-002-02", "marketing_start_date": "20240821"}], "brand_name": "Tadalafil", "product_id": "82968-002_464c2d55-32ca-db41-e063-6294a90a9103", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "82968-002", "generic_name": "Tadalafil", "labeler_name": "FOURRTS (INDIA) LABORATORIES PRIVATE LIMITED", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tadalafil", "active_ingredients": [{"name": "TADALAFIL", "strength": "5 mg/1"}], "application_number": "ANDA217606", "marketing_category": "ANDA", "marketing_start_date": "20240821", "listing_expiration_date": "20261231"}