tadalafil

Generic: tadalafil

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

Drug Facts

Product Profile

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

tadalafil 5 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3697
Product ID 70518-3697_3b112723-94c9-0800-e063-6394a90a4d39
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209250
Listing Expiration 2026-12-31
Marketing Start 2023-04-02

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 705183697
Hyphenated Format 70518-3697

Supplemental Identifiers

RxCUI
403957
UNII
742SXX0ICT
NUI
N0000175599 N0000020026

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 ANDA209250 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 250 POUCH in 1 BOX (70518-3697-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-3697-1)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3697-2)
source: ndc

Packages (2)

70518-3697-0 250 POUCH in 1 BOX (70518-3697-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-3697-1) 70518-3697-2 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3697-2)

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": "3b112723-94c9-0800-e063-6394a90a4d39", "openfda": {"nui": ["N0000175599", "N0000020026"], "unii": ["742SXX0ICT"], "rxcui": ["403957"], "spl_set_id": ["b927f04e-63d2-4d3d-bc07-93d85f5a29c6"], "pharm_class_epc": ["Phosphodiesterase 5 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 5 Inhibitors [MoA]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "250 POUCH in 1 BOX (70518-3697-0)  / 1 TABLET, FILM COATED in 1 POUCH (70518-3697-1)", "package_ndc": "70518-3697-0", "marketing_start_date": "20230402"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3697-2)", "package_ndc": "70518-3697-2", "marketing_start_date": "20240110"}], "brand_name": "tadalafil", "product_id": "70518-3697_3b112723-94c9-0800-e063-6394a90a4d39", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "70518-3697", "generic_name": "tadalafil", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "tadalafil", "active_ingredients": [{"name": "TADALAFIL", "strength": "5 mg/1"}], "application_number": "ANDA209250", "marketing_category": "ANDA", "marketing_start_date": "20230402", "listing_expiration_date": "20261231"}