tadalafil

Generic: tadalafil

Labeler: ani pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tadalafil
Generic Name tadalafil
Labeler ani pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

tadalafil 5 mg/1

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70954-433
Product ID 70954-433_1dace1e7-c617-492f-bb0d-141bf4e673db
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215949
Listing Expiration 2026-12-31
Marketing Start 2023-03-06

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 70954433
Hyphenated Format 70954-433

Supplemental Identifiers

RxCUI
402019 403957 484814
UPC
0370954434108 0370954435105 0370954433101
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 ANDA215949 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (70954-433-10)
source: ndc

Packages (1)

70954-433-10 30 TABLET in 1 BOTTLE (70954-433-10)

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": "1dace1e7-c617-492f-bb0d-141bf4e673db", "openfda": {"nui": ["N0000175599", "N0000020026"], "upc": ["0370954434108", "0370954435105", "0370954433101"], "unii": ["742SXX0ICT"], "rxcui": ["402019", "403957", "484814"], "spl_set_id": ["1dace1e7-c617-492f-bb0d-141bf4e673db"], "pharm_class_epc": ["Phosphodiesterase 5 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 5 Inhibitors [MoA]"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (70954-433-10)", "package_ndc": "70954-433-10", "marketing_start_date": "20230306"}], "brand_name": "Tadalafil", "product_id": "70954-433_1dace1e7-c617-492f-bb0d-141bf4e673db", "dosage_form": "TABLET", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "70954-433", "generic_name": "Tadalafil", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tadalafil", "active_ingredients": [{"name": "TADALAFIL", "strength": "5 mg/1"}], "application_number": "ANDA215949", "marketing_category": "ANDA", "marketing_start_date": "20230306", "listing_expiration_date": "20261231"}