35561-254

Generic: tadalafil

Labeler: bostal llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name
Generic Name tadalafil
Labeler bostal llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

tadalafil 2.5 mg/1

Manufacturer
Bostal LLC

Identifiers & Regulatory

Product NDC 35561-254
Product ID 35561-254_49fc9e85-3dc2-064f-e063-6294a90af582
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208824
Listing Expiration 2027-12-31
Marketing Start 2019-11-29

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 35561254
Hyphenated Format 35561-254

Supplemental Identifiers

RxCUI
402019 403957 484814 757707
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 n/a (source: label)
Generic Name tadalafil (source: ndc)
Application Number ANDA208824 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (35561-254-10)
  • 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (35561-254-13)
source: ndc

Packages (2)

35561-254-10 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (35561-254-10) 35561-254-13 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (35561-254-13)

Ingredients (1)

tadalafil (2.5 mg/1)

Linked Drug Pages (1)

N/A ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "49fc9e85-3dc2-064f-e063-6294a90af582", "openfda": {"nui": ["N0000175599", "N0000020026"], "unii": ["742SXX0ICT"], "rxcui": ["402019", "403957", "484814", "757707"], "spl_set_id": ["78509a43-a907-4359-9022-f38c4f765880"], "pharm_class_epc": ["Phosphodiesterase 5 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 5 Inhibitors [MoA]"], "manufacturer_name": ["Bostal LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (35561-254-10)", "package_ndc": "35561-254-10", "marketing_start_date": "20191129"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (35561-254-13)", "package_ndc": "35561-254-13", "marketing_start_date": "20191129"}], "product_id": "35561-254_49fc9e85-3dc2-064f-e063-6294a90af582", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "35561-254", "generic_name": "Tadalafil", "labeler_name": "Bostal LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": null, "active_ingredients": [{"name": "TADALAFIL", "strength": "2.5 mg/1"}], "application_number": "ANDA208824", "marketing_category": "ANDA", "marketing_start_date": "20191129", "listing_expiration_date": "20271231"}