tadalafil

Generic: tadalafil

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

Drug Facts

Product Profile

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

tadalafil 5 mg/1

Manufacturer
Alembic Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 62332-178
Product ID 62332-178_76b22a5c-175e-433e-bd1e-5fefb0a78d5f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204809
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 62332178
Hyphenated Format 62332-178

Supplemental Identifiers

RxCUI
402019 403957 484814 757707
UPC
0362332180301 0362332178308 0362332177301 0362332179305
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 ANDA204809 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, COATED in 1 CARTON (62332-178-15)
  • 30 TABLET, COATED in 1 BOTTLE (62332-178-30)
  • 500 TABLET, COATED in 1 BOTTLE (62332-178-71)
  • 1000 TABLET, COATED in 1 BOTTLE (62332-178-91)
source: ndc

Packages (4)

62332-178-15 30 TABLET, COATED in 1 CARTON (62332-178-15) 62332-178-30 30 TABLET, COATED in 1 BOTTLE (62332-178-30) 62332-178-71 500 TABLET, COATED in 1 BOTTLE (62332-178-71) 62332-178-91 1000 TABLET, COATED in 1 BOTTLE (62332-178-91)

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": "76b22a5c-175e-433e-bd1e-5fefb0a78d5f", "openfda": {"nui": ["N0000175599", "N0000020026"], "upc": ["0362332180301", "0362332178308", "0362332177301", "0362332179305"], "unii": ["742SXX0ICT"], "rxcui": ["402019", "403957", "484814", "757707"], "spl_set_id": ["abcb2cda-9b3f-45f6-ad5f-c2370b0dd114"], "pharm_class_epc": ["Phosphodiesterase 5 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 5 Inhibitors [MoA]"], "manufacturer_name": ["Alembic Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, COATED in 1 CARTON (62332-178-15)", "package_ndc": "62332-178-15", "marketing_start_date": "20190326"}, {"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE (62332-178-30)", "package_ndc": "62332-178-30", "marketing_start_date": "20190326"}, {"sample": false, "description": "500 TABLET, COATED in 1 BOTTLE (62332-178-71)", "package_ndc": "62332-178-71", "marketing_start_date": "20240802"}, {"sample": false, "description": "1000 TABLET, COATED in 1 BOTTLE (62332-178-91)", "package_ndc": "62332-178-91", "marketing_start_date": "20240802"}], "brand_name": "Tadalafil", "product_id": "62332-178_76b22a5c-175e-433e-bd1e-5fefb0a78d5f", "dosage_form": "TABLET, COATED", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "62332-178", "generic_name": "tadalafil", "labeler_name": "Alembic Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tadalafil", "active_ingredients": [{"name": "TADALAFIL", "strength": "5 mg/1"}], "application_number": "ANDA204809", "marketing_category": "ANDA", "marketing_start_date": "20190326", "listing_expiration_date": "20261231"}