ciclopirox

Generic: ciclopirox

Labeler: acella pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ciclopirox
Generic Name ciclopirox
Labeler acella pharmaceuticals, llc
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

ciclopirox 80 mg/mL

Manufacturer
Acella Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 42192-715
Product ID 42192-715_955307bc-4c2a-4d14-a1de-074a36e5ad92
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078172
Listing Expiration 2026-12-31
Marketing Start 2019-11-04

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 42192715
Hyphenated Format 42192-715

Supplemental Identifiers

RxCUI
309291
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 ANDA078172 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (42192-715-06) / 6.6 mL in 1 BOTTLE
source: ndc

Packages (1)

42192-715-06 1 BOTTLE in 1 CARTON (42192-715-06) / 6.6 mL in 1 BOTTLE

Ingredients (1)

ciclopirox (80 mg/mL)

Linked Drug Pages (1)

Ciclopirox ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "955307bc-4c2a-4d14-a1de-074a36e5ad92", "openfda": {"nui": ["N0000008577", "N0000008841", "N0000008853", "N0000000150"], "unii": ["19W019ZDRJ"], "rxcui": ["309291"], "spl_set_id": ["a08137a9-331f-4615-9752-e2cb52b3d8fc"], "pharm_class_pe": ["Decreased DNA Replication [PE]", "Decreased Protein Synthesis [PE]", "Decreased RNA Replication [PE]"], "pharm_class_moa": ["Protein Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Acella Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (42192-715-06)  / 6.6 mL in 1 BOTTLE", "package_ndc": "42192-715-06", "marketing_start_date": "20191104"}], "brand_name": "Ciclopirox", "product_id": "42192-715_955307bc-4c2a-4d14-a1de-074a36e5ad92", "dosage_form": "SOLUTION", "pharm_class": ["Decreased DNA Replication [PE]", "Decreased Protein Synthesis [PE]", "Decreased RNA Replication [PE]", "Protein Synthesis Inhibitors [MoA]"], "product_ndc": "42192-715", "generic_name": "Ciclopirox", "labeler_name": "Acella Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ciclopirox", "active_ingredients": [{"name": "CICLOPIROX", "strength": "80 mg/mL"}], "application_number": "ANDA078172", "marketing_category": "ANDA", "marketing_start_date": "20191104", "listing_expiration_date": "20261231"}