tadalafil

Generic: tadalafil

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

Drug Facts

Product Profile

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

tadalafil 2.5 mg/1

Manufacturer
Teva Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0480-2308
Product ID 0480-2308_f56140f5-edaf-4ede-a7a4-4506caaca572
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205885
Listing Expiration 2026-12-31
Marketing Start 2024-11-06

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 04802308
Hyphenated Format 0480-2308

Supplemental Identifiers

RxCUI
402019 403957 484814 757707
UPC
0304802310566 0304802311563 0304802309560
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 ANDA205885 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Tadalafil tablets, USP are supplied as follows: 5 mg pale yellow, oval-shaped, film-coated tablets, debossed with ‘09’ on one side and plain on the other side. Bottles of 30 NDC 0480-2309-56 10 mg pale yellow, oval-shaped, film-coated tablets, debossed with ‘10’ on one side and plain on the other side. Bottles of 30 NDC 0480-2310-56 20 mg pale yellow, oval-shaped, film-coated tablets, debossed with ‘11’ on one side and plain on the other side. Bottles of 30 NDC 0480-2311-56 16.2 Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep out of reach of children.
  • 16.1 How Supplied Tadalafil tablets, USP are supplied as follows: 5 mg pale yellow, oval-shaped, film-coated tablets, debossed with ‘09’ on one side and plain on the other side. Bottles of 30 NDC 0480-2309-56 10 mg pale yellow, oval-shaped, film-coated tablets, debossed with ‘10’ on one side and plain on the other side. Bottles of 30 NDC 0480-2310-56 20 mg pale yellow, oval-shaped, film-coated tablets, debossed with ‘11’ on one side and plain on the other side. Bottles of 30 NDC 0480-2311-56
  • PRINCIPAL DISPLAY PANEL New NDC New Product Appearance NDC 0480-2308-65 Tadalafil Tablets, USP 2.5 mg Tablets should not be split. Entire dose should be taken. Rx only 30 Tablets (2 cards of 15 tablets) 30 tablets
  • PRINCIPAL DISPLAY PANEL NDC 0480-2309-56 Tadalafil Tablets, USP 5 mg Tablets should not be split. Entire dose should be taken. Rx only 30 Tablets new
  • PRINCIPAL DISPLAY PANEL NDC 0480-2310-56 Tadalafil Tablets, USP 10 mg Tablets should not be split. Entire dose should be taken. Rx only 30 Tablets new
  • PRINCIPAL DISPLAY PANEL NDC 0480-2311-56 Tadalafil Tablets, USP 20 mg Tablets should not be split. Entire dose should be taken. Rx only 30 Tablets new
source: label

Packages (0)

No package records.

Ingredients (1)

tadalafil (2.5 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": "f56140f5-edaf-4ede-a7a4-4506caaca572", "openfda": {"nui": ["N0000175599", "N0000020026"], "upc": ["0304802310566", "0304802311563", "0304802309560"], "unii": ["742SXX0ICT"], "rxcui": ["402019", "403957", "484814", "757707"], "spl_set_id": ["3ad14d63-42e7-493f-b56c-e02a4fd139f7"], "pharm_class_epc": ["Phosphodiesterase 5 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 5 Inhibitors [MoA]"], "manufacturer_name": ["Teva Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Tadalafil", "product_id": "0480-2308_f56140f5-edaf-4ede-a7a4-4506caaca572", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "0480-2308", "generic_name": "Tadalafil", "labeler_name": "Teva Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tadalafil", "active_ingredients": [{"name": "TADALAFIL", "strength": "2.5 mg/1"}], "application_number": "ANDA205885", "marketing_category": "ANDA", "marketing_start_date": "20241106", "listing_expiration_date": "20261231"}