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 10 mg/1

Identifiers & Regulatory

Product NDC 0480-2310
Product ID 0480-2310_84ad5d1f-f226-4562-a511-2046f388d2a1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205885
Listing Expiration 2027-12-31
Marketing Start 2024-02-07

Pharmacologic Class

Classes
phosphodiesterase 5 inhibitor [epc] phosphodiesterase 5 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04802310
Hyphenated Format 0480-2310

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
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (0480-2310-56)
source: ndc

Packages (1)

0480-2310-56 30 TABLET, FILM COATED in 1 BOTTLE (0480-2310-56)

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": "84ad5d1f-f226-4562-a511-2046f388d2a1", "openfda": {}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (0480-2310-56)", "package_ndc": "0480-2310-56", "marketing_start_date": "20240207"}], "brand_name": "Tadalafil", "product_id": "0480-2310_84ad5d1f-f226-4562-a511-2046f388d2a1", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "0480-2310", "generic_name": "Tadalafil", "labeler_name": "Teva Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tadalafil", "active_ingredients": [{"name": "TADALAFIL", "strength": "10 mg/1"}], "application_number": "ANDA205885", "marketing_category": "ANDA", "marketing_start_date": "20240207", "listing_expiration_date": "20271231"}