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
Routes
ORAL
Active Ingredients

tadalafil 5 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3434
Product ID 70518-3434_468e33b8-43f4-324c-e063-6294a90a5972
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209654
Listing Expiration 2026-12-31
Marketing Start 2022-06-09

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 705183434
Hyphenated Format 70518-3434

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 ANDA209654 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 250 POUCH in 1 BOX (70518-3434-2) / 1 TABLET in 1 POUCH (70518-3434-1)
  • 30 TABLET in 1 BOTTLE, PLASTIC (70518-3434-4)
source: ndc

Packages (2)

70518-3434-2 250 POUCH in 1 BOX (70518-3434-2) / 1 TABLET in 1 POUCH (70518-3434-1) 70518-3434-4 30 TABLET in 1 BOTTLE, PLASTIC (70518-3434-4)

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": "468e33b8-43f4-324c-e063-6294a90a5972", "openfda": {"nui": ["N0000175599", "N0000020026"], "unii": ["742SXX0ICT"], "rxcui": ["403957"], "spl_set_id": ["415bd983-86f3-4f38-917a-9805024f31cb"], "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 (70518-3434-2)  / 1 TABLET in 1 POUCH (70518-3434-1)", "package_ndc": "70518-3434-2", "marketing_start_date": "20220623"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (70518-3434-4)", "package_ndc": "70518-3434-4", "marketing_start_date": "20230103"}], "brand_name": "Tadalafil", "product_id": "70518-3434_468e33b8-43f4-324c-e063-6294a90a5972", "dosage_form": "TABLET", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "70518-3434", "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": "ANDA209654", "marketing_category": "ANDA", "marketing_start_date": "20220609", "listing_expiration_date": "20261231"}