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 20 mg/1

Manufacturer
Dr.Reddys Laboratories Inc

Identifiers & Regulatory

Product NDC 43598-578
Product ID 43598-578_e0893959-da34-2bf9-3a3e-3b89974f13dd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210145
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 43598578
Hyphenated Format 43598-578

Supplemental Identifiers

RxCUI
2123194
UPC
0343598578606
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 ANDA210145 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (43598-578-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (43598-578-60)
source: ndc

Packages (2)

43598-578-30 30 TABLET, FILM COATED in 1 BOTTLE (43598-578-30) 43598-578-60 60 TABLET, FILM COATED in 1 BOTTLE (43598-578-60)

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": "e0893959-da34-2bf9-3a3e-3b89974f13dd", "openfda": {"nui": ["N0000175599", "N0000020026"], "upc": ["0343598578606"], "unii": ["742SXX0ICT"], "rxcui": ["2123194"], "spl_set_id": ["61955171-ca57-e300-1983-9472a56ca976"], "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 (43598-578-30)", "package_ndc": "43598-578-30", "marketing_start_date": "20190205"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (43598-578-60)", "package_ndc": "43598-578-60", "marketing_start_date": "20190205"}], "brand_name": "Tadalafil", "product_id": "43598-578_e0893959-da34-2bf9-3a3e-3b89974f13dd", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "43598-578", "generic_name": "Tadalafil", "labeler_name": "Dr.Reddys Laboratories Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tadalafil", "active_ingredients": [{"name": "TADALAFIL", "strength": "20 mg/1"}], "application_number": "ANDA210145", "marketing_category": "ANDA", "marketing_start_date": "20190205", "listing_expiration_date": "20261231"}