tadalafil

Generic: tadalafil

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

Drug Facts

Product Profile

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

tadalafil 20 mg/1

Manufacturer
Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-526
Product ID 69097-526_f5c8b23e-51e5-4264-8328-437c9d11939a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210255
Listing Expiration 2026-12-31
Marketing Start 2019-02-05

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 69097526
Hyphenated Format 69097-526

Supplemental Identifiers

RxCUI
2123194
UPC
0369097526030
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 ANDA210255 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (69097-526-03)
  • 4 TABLET, FILM COATED in 1 CARTON (69097-526-16)
source: ndc

Packages (2)

69097-526-03 60 TABLET, FILM COATED in 1 BOTTLE (69097-526-03) 69097-526-16 4 TABLET, FILM COATED in 1 CARTON (69097-526-16)

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": "f5c8b23e-51e5-4264-8328-437c9d11939a", "openfda": {"nui": ["N0000175599", "N0000020026"], "upc": ["0369097526030"], "unii": ["742SXX0ICT"], "rxcui": ["2123194"], "spl_set_id": ["cf6fc925-ad20-4ed0-9356-15d24afa8d0b"], "pharm_class_epc": ["Phosphodiesterase 5 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 5 Inhibitors [MoA]"], "manufacturer_name": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (69097-526-03)", "package_ndc": "69097-526-03", "marketing_start_date": "20190205"}, {"sample": false, "description": "4 TABLET, FILM COATED in 1 CARTON (69097-526-16)", "package_ndc": "69097-526-16", "marketing_start_date": "20190205"}], "brand_name": "Tadalafil", "product_id": "69097-526_f5c8b23e-51e5-4264-8328-437c9d11939a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "69097-526", "generic_name": "Tadalafil", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tadalafil", "active_ingredients": [{"name": "TADALAFIL", "strength": "20 mg/1"}], "application_number": "ANDA210255", "marketing_category": "ANDA", "marketing_start_date": "20190205", "listing_expiration_date": "20261231"}