tadalafil

Generic: tadalafil

Labeler: dr.reddys laboratories inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tadalafil
Generic Name tadalafil
Labeler dr.reddys laboratories inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

tadalafil 5 mg/1

Manufacturer
Dr.Reddys Laboratories Inc

Identifiers & Regulatory

Product NDC 43598-575
Product ID 43598-575_7d8af9db-e459-1195-41b8-67f96e390ef2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210069
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 43598575
Hyphenated Format 43598-575

Supplemental Identifiers

RxCUI
402019 403957 484814 757707
UPC
0343598573304 0343598574301 0343598576305 0343598575308
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 ANDA210069 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (43598-575-30)
  • 3 BLISTER PACK in 1 CARTON (43598-575-31) / 10 TABLET, FILM COATED in 1 BLISTER PACK (43598-575-79)
source: ndc

Packages (2)

43598-575-30 30 TABLET, FILM COATED in 1 BOTTLE (43598-575-30) 43598-575-31 3 BLISTER PACK in 1 CARTON (43598-575-31) / 10 TABLET, FILM COATED in 1 BLISTER PACK (43598-575-79)

Ingredients (1)

tadalafil (5 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": "7d8af9db-e459-1195-41b8-67f96e390ef2", "openfda": {"nui": ["N0000175599", "N0000020026"], "upc": ["0343598573304", "0343598574301", "0343598576305", "0343598575308"], "unii": ["742SXX0ICT"], "rxcui": ["402019", "403957", "484814", "757707"], "spl_set_id": ["22b8a2e3-d1b8-f193-45fa-77cc62a1b941"], "pharm_class_epc": ["Phosphodiesterase 5 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 5 Inhibitors [MoA]"], "manufacturer_name": ["Dr.Reddys Laboratories Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (43598-575-30)", "package_ndc": "43598-575-30", "marketing_start_date": "20190326"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (43598-575-31)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (43598-575-79)", "package_ndc": "43598-575-31", "marketing_start_date": "20200407"}], "brand_name": "Tadalafil", "product_id": "43598-575_7d8af9db-e459-1195-41b8-67f96e390ef2", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "43598-575", "generic_name": "Tadalafil", "labeler_name": "Dr.Reddys Laboratories Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tadalafil", "active_ingredients": [{"name": "TADALAFIL", "strength": "5 mg/1"}], "application_number": "ANDA210069", "marketing_category": "ANDA", "marketing_start_date": "20190326", "listing_expiration_date": "20261231"}