tadalafil

Generic: tadalafil

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

Drug Facts

Product Profile

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

tadalafil 20 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-914
Product ID 68180-914_0c0d591e-f35b-4e3d-bdcb-7d3a1c8e6a2f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210572
Listing Expiration 2026-12-31
Marketing Start 2019-02-11

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 68180914
Hyphenated Format 68180-914

Supplemental Identifiers

RxCUI
2123194
UPC
0368180914068
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 ANDA210572 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Tadalafil Tablets USP are supplied as follows: 20 mg orange colored, round shaped, biconvex film coated tablets debossed with 'L 124' on one side and plain on other side. Bottles of 30 NDC 68180-914-06 Bottles of 60 NDC 68180-914-07 16.2 Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 68180-914-06 Tadalafil Tablets USP 20 mg Pack of 30 tablets image-05
source: label

Packages (0)

No package records.

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": "0c0d591e-f35b-4e3d-bdcb-7d3a1c8e6a2f", "openfda": {"nui": ["N0000175599", "N0000020026"], "upc": ["0368180914068"], "unii": ["742SXX0ICT"], "rxcui": ["2123194"], "spl_set_id": ["efa03afa-c412-4b31-bf26-7c3a6f7311af"], "pharm_class_epc": ["Phosphodiesterase 5 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 5 Inhibitors [MoA]"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Tadalafil", "product_id": "68180-914_0c0d591e-f35b-4e3d-bdcb-7d3a1c8e6a2f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "68180-914", "generic_name": "Tadalafil", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tadalafil", "active_ingredients": [{"name": "TADALAFIL", "strength": "20 mg/1"}], "application_number": "ANDA210572", "marketing_category": "ANDA", "marketing_start_date": "20190211", "listing_expiration_date": "20261231"}