ciclopirox

Generic: ciclopirox

Labeler: encube ethicals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ciclopirox
Generic Name ciclopirox
Labeler encube ethicals, inc.
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

ciclopirox 80 mg/mL

Manufacturer
Encube Ethicals, Inc.

Identifiers & Regulatory

Product NDC 21922-053
Product ID 21922-053_c81092f6-fe1e-4f70-8699-69c4cdce214f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077687
Listing Expiration 2026-12-31
Marketing Start 2023-11-09

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 21922053
Hyphenated Format 21922-053

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 ANDA077687 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, WITH APPLICATOR in 1 CARTON (21922-053-51) / 6.6 mL in 1 BOTTLE, WITH APPLICATOR
source: ndc

Packages (1)

21922-053-51 1 BOTTLE, WITH APPLICATOR in 1 CARTON (21922-053-51) / 6.6 mL in 1 BOTTLE, WITH APPLICATOR

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": "c81092f6-fe1e-4f70-8699-69c4cdce214f", "openfda": {"nui": ["N0000008577", "N0000008841", "N0000008853", "N0000000150"], "unii": ["19W019ZDRJ"], "rxcui": ["309291"], "spl_set_id": ["79084b47-7481-4926-9837-e08f633b1ddf"], "pharm_class_pe": ["Decreased DNA Replication [PE]", "Decreased Protein Synthesis [PE]", "Decreased RNA Replication [PE]"], "pharm_class_moa": ["Protein Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Encube Ethicals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, WITH APPLICATOR in 1 CARTON (21922-053-51)  / 6.6 mL in 1 BOTTLE, WITH APPLICATOR", "package_ndc": "21922-053-51", "marketing_start_date": "20231109"}], "brand_name": "CICLOPIROX", "product_id": "21922-053_c81092f6-fe1e-4f70-8699-69c4cdce214f", "dosage_form": "SOLUTION", "pharm_class": ["Decreased DNA Replication [PE]", "Decreased Protein Synthesis [PE]", "Decreased RNA Replication [PE]", "Protein Synthesis Inhibitors [MoA]"], "product_ndc": "21922-053", "generic_name": "ciclopirox", "labeler_name": "Encube Ethicals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CICLOPIROX", "active_ingredients": [{"name": "CICLOPIROX", "strength": "80 mg/mL"}], "application_number": "ANDA077687", "marketing_category": "ANDA", "marketing_start_date": "20231109", "listing_expiration_date": "20261231"}