ciclopirox

Generic: ciclopirox

Labeler: padagis us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ciclopirox
Generic Name ciclopirox
Labeler padagis us llc
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

ciclopirox 7.7 mg/g

Manufacturer
Padagis US LLC

Identifiers & Regulatory

Product NDC 0574-2061
Product ID 0574-2061_04609ea1-41be-4aa6-ad71-7424db6ae548
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078266
Listing Expiration 2026-12-31
Marketing Start 2009-01-07

Pharmacologic Class

Mechanism of Action
protein synthesis inhibitors [moa]
Physiologic Effect
decreased dna replication [pe] decreased protein synthesis [pe] decreased rna replication [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05742061
Hyphenated Format 0574-2061

Supplemental Identifiers

RxCUI
313941
UNII
19W019ZDRJ
NUI
N0000008577 N0000008841 N0000008853 N0000000150

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 ciclopirox (source: ndc)
Generic Name ciclopirox (source: ndc)
Application Number ANDA078266 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 7.7 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0574-2061-01) / 100 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0574-2061-30) / 30 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0574-2061-45) / 45 g in 1 TUBE
source: ndc

Packages (3)

0574-2061-01 1 TUBE in 1 CARTON (0574-2061-01) / 100 g in 1 TUBE 0574-2061-30 1 TUBE in 1 CARTON (0574-2061-30) / 30 g in 1 TUBE 0574-2061-45 1 TUBE in 1 CARTON (0574-2061-45) / 45 g in 1 TUBE

Ingredients (1)

ciclopirox (7.7 mg/g)

Linked Drug Pages (1)

CICLOPIROX ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "04609ea1-41be-4aa6-ad71-7424db6ae548", "openfda": {"nui": ["N0000008577", "N0000008841", "N0000008853", "N0000000150"], "unii": ["19W019ZDRJ"], "rxcui": ["313941"], "spl_set_id": ["b6a02568-867b-4c7b-890f-5d28bf0b363d"], "pharm_class_pe": ["Decreased DNA Replication [PE]", "Decreased Protein Synthesis [PE]", "Decreased RNA Replication [PE]"], "pharm_class_moa": ["Protein Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Padagis US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0574-2061-01)  / 100 g in 1 TUBE", "package_ndc": "0574-2061-01", "marketing_start_date": "20090107"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0574-2061-30)  / 30 g in 1 TUBE", "package_ndc": "0574-2061-30", "marketing_start_date": "20090107"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0574-2061-45)  / 45 g in 1 TUBE", "package_ndc": "0574-2061-45", "marketing_start_date": "20090107"}], "brand_name": "CICLOPIROX", "product_id": "0574-2061_04609ea1-41be-4aa6-ad71-7424db6ae548", "dosage_form": "GEL", "pharm_class": ["Decreased DNA Replication [PE]", "Decreased Protein Synthesis [PE]", "Decreased RNA Replication [PE]", "Protein Synthesis Inhibitors [MoA]"], "product_ndc": "0574-2061", "generic_name": "CICLOPIROX", "labeler_name": "Padagis US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CICLOPIROX", "active_ingredients": [{"name": "CICLOPIROX", "strength": "7.7 mg/g"}], "application_number": "ANDA078266", "marketing_category": "ANDA", "marketing_start_date": "20090107", "listing_expiration_date": "20261231"}