tadalafil

Generic: tadalafil

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tadalafil
Generic Name tadalafil
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

tadalafil 5 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-010
Product ID 47335-010_5f176ab2-0dba-4418-8aee-27a110ed6396
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208934
Listing Expiration 2026-12-31
Marketing Start 2019-03-26

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 47335010
Hyphenated Format 47335-010

Supplemental Identifiers

RxCUI
402019 403957 484814 757707
UPC
0347335010831 0347335012835 0347335011838
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 ANDA208934 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (47335-010-64) / 15 TABLET, FILM COATED in 1 BLISTER PACK
  • 30 TABLET, FILM COATED in 1 BOTTLE (47335-010-83)
source: ndc

Packages (2)

47335-010-64 2 BLISTER PACK in 1 CARTON (47335-010-64) / 15 TABLET, FILM COATED in 1 BLISTER PACK 47335-010-83 30 TABLET, FILM COATED in 1 BOTTLE (47335-010-83)

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": "5f176ab2-0dba-4418-8aee-27a110ed6396", "openfda": {"nui": ["N0000175599", "N0000020026"], "upc": ["0347335010831", "0347335012835", "0347335011838"], "unii": ["742SXX0ICT"], "rxcui": ["402019", "403957", "484814", "757707"], "spl_set_id": ["168a135b-1454-4def-9b03-c9a470bfcb5f"], "pharm_class_epc": ["Phosphodiesterase 5 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 5 Inhibitors [MoA]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (47335-010-64)  / 15 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "47335-010-64", "marketing_start_date": "20190326"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (47335-010-83)", "package_ndc": "47335-010-83", "marketing_start_date": "20190326"}], "brand_name": "Tadalafil", "product_id": "47335-010_5f176ab2-0dba-4418-8aee-27a110ed6396", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "47335-010", "generic_name": "Tadalafil", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tadalafil", "active_ingredients": [{"name": "TADALAFIL", "strength": "5 mg/1"}], "application_number": "ANDA208934", "marketing_category": "ANDA", "marketing_start_date": "20190326", "listing_expiration_date": "20261231"}