tadalafil

Generic: tadalafil

Labeler: ajanta pharma usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tadalafil
Generic Name tadalafil
Labeler ajanta pharma usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

tadalafil 20 mg/1

Manufacturer
Ajanta Pharma USA Inc.

Identifiers & Regulatory

Product NDC 27241-123
Product ID 27241-123_e21837f2-58d2-4fb1-87b3-f751b94312a9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210392
Listing Expiration 2026-12-31
Marketing Start 2022-07-04

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 27241123
Hyphenated Format 27241-123

Supplemental Identifiers

RxCUI
2123194
UPC
0327241123023
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 ANDA210392 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (27241-123-02)
source: ndc

Packages (1)

27241-123-02 60 TABLET in 1 BOTTLE (27241-123-02)

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": "e21837f2-58d2-4fb1-87b3-f751b94312a9", "openfda": {"nui": ["N0000175599", "N0000020026"], "upc": ["0327241123023"], "unii": ["742SXX0ICT"], "rxcui": ["2123194"], "spl_set_id": ["fceb8aaf-b4eb-4004-8ca4-f004eac6b314"], "pharm_class_epc": ["Phosphodiesterase 5 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 5 Inhibitors [MoA]"], "manufacturer_name": ["Ajanta Pharma USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (27241-123-02)", "package_ndc": "27241-123-02", "marketing_start_date": "20220704"}], "brand_name": "Tadalafil", "product_id": "27241-123_e21837f2-58d2-4fb1-87b3-f751b94312a9", "dosage_form": "TABLET", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "27241-123", "generic_name": "Tadalafil", "labeler_name": "Ajanta Pharma USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tadalafil", "active_ingredients": [{"name": "TADALAFIL", "strength": "20 mg/1"}], "application_number": "ANDA210392", "marketing_category": "ANDA", "marketing_start_date": "20220704", "listing_expiration_date": "20261231"}