tadalafil

Generic: tadalafil

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

Drug Facts

Product Profile

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

tadalafil 20 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-180
Product ID 46708-180_53d81162-1774-48a1-b19b-f2b0e2d1020a
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 46708180
Hyphenated Format 46708-180

Supplemental Identifiers

RxCUI
402019 403957 484814 757707
UPC
0346708178307 0346708180300
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
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET, COATED in 1 BOTTLE (46708-180-30)
  • 500 TABLET, COATED in 1 BOTTLE (46708-180-71)
  • 1000 TABLET, COATED in 1 BOTTLE (46708-180-91)
source: ndc

Packages (3)

46708-180-30 30 TABLET, COATED in 1 BOTTLE (46708-180-30) 46708-180-71 500 TABLET, COATED in 1 BOTTLE (46708-180-71) 46708-180-91 1000 TABLET, COATED in 1 BOTTLE (46708-180-91)

Ingredients (1)

tadalafil (20 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": "53d81162-1774-48a1-b19b-f2b0e2d1020a", "openfda": {"nui": ["N0000175599", "N0000020026"], "upc": ["0346708178307", "0346708180300"], "unii": ["742SXX0ICT"], "rxcui": ["402019", "403957", "484814", "757707"], "spl_set_id": ["741102c1-8809-44d4-9098-3dc8c0604764"], "pharm_class_epc": ["Phosphodiesterase 5 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 5 Inhibitors [MoA]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE (46708-180-30)", "package_ndc": "46708-180-30", "marketing_start_date": "20190326"}, {"sample": false, "description": "500 TABLET, COATED in 1 BOTTLE (46708-180-71)", "package_ndc": "46708-180-71", "marketing_start_date": "20240802"}, {"sample": false, "description": "1000 TABLET, COATED in 1 BOTTLE (46708-180-91)", "package_ndc": "46708-180-91", "marketing_start_date": "20240802"}], "brand_name": "Tadalafil", "product_id": "46708-180_53d81162-1774-48a1-b19b-f2b0e2d1020a", "dosage_form": "TABLET, COATED", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "46708-180", "generic_name": "tadalafil", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tadalafil", "active_ingredients": [{"name": "TADALAFIL", "strength": "20 mg/1"}], "application_number": "ANDA204809", "marketing_category": "ANDA", "marketing_start_date": "20190326", "listing_expiration_date": "20261231"}