tadalafil

Generic: tadalafil

Labeler: camber pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

tadalafil 10 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-645
Product ID 31722-645_a3892605-4eb1-4d6e-a675-f7f7d4302f38
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209908
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 31722645
Hyphenated Format 31722-645

Supplemental Identifiers

RxCUI
402019 403957 484814 757707
UPC
0331722646307
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 ANDA209908 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (31722-645-30)
  • 10 BLISTER PACK in 1 CARTON (31722-645-31) / 10 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (2)

31722-645-30 30 TABLET, FILM COATED in 1 BOTTLE (31722-645-30) 31722-645-31 10 BLISTER PACK in 1 CARTON (31722-645-31) / 10 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

tadalafil (10 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": "a3892605-4eb1-4d6e-a675-f7f7d4302f38", "openfda": {"nui": ["N0000175599", "N0000020026"], "upc": ["0331722646307"], "unii": ["742SXX0ICT"], "rxcui": ["402019", "403957", "484814", "757707"], "spl_set_id": ["a3892605-4eb1-4d6e-a675-f7f7d4302f38"], "pharm_class_epc": ["Phosphodiesterase 5 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 5 Inhibitors [MoA]"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (31722-645-30)", "package_ndc": "31722-645-30", "marketing_start_date": "20190326"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (31722-645-31)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "31722-645-31", "marketing_start_date": "20190326"}], "brand_name": "Tadalafil", "product_id": "31722-645_a3892605-4eb1-4d6e-a675-f7f7d4302f38", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "31722-645", "generic_name": "Tadalafil", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tadalafil", "active_ingredients": [{"name": "TADALAFIL", "strength": "10 mg/1"}], "application_number": "ANDA209908", "marketing_category": "ANDA", "marketing_start_date": "20190326", "listing_expiration_date": "20261231"}