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 70518-3864
Product ID 70518-3864_3f8ca6f6-bd76-cc58-e063-6294a90a725e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210609
Listing Expiration 2026-12-31
Marketing Start 2023-09-18

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 705183864
Hyphenated Format 70518-3864

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 ANDA210609 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (70518-3864-0)
source: ndc

Packages (1)

70518-3864-0 30 TABLET in 1 BOTTLE, PLASTIC (70518-3864-0)

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": "3f8ca6f6-bd76-cc58-e063-6294a90a725e", "openfda": {"nui": ["N0000175599", "N0000020026"], "unii": ["742SXX0ICT"], "rxcui": ["403957"], "spl_set_id": ["89a33a41-0f01-4f29-8b2f-769d649fbdcb"], "pharm_class_epc": ["Phosphodiesterase 5 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 5 Inhibitors [MoA]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (70518-3864-0)", "package_ndc": "70518-3864-0", "marketing_start_date": "20230918"}], "brand_name": "TADALAFIL", "product_id": "70518-3864_3f8ca6f6-bd76-cc58-e063-6294a90a725e", "dosage_form": "TABLET", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "70518-3864", "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": "ANDA210609", "marketing_category": "ANDA", "marketing_start_date": "20230918", "listing_expiration_date": "20261231"}