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 SHAMPOO
Routes
TOPICAL
Active Ingredients

ciclopirox 1 g/100mL

Manufacturer
Encube Ethicals, Inc.

Identifiers & Regulatory

Product NDC 21922-105
Product ID 21922-105_1b7b23aa-fc6d-4b37-b5db-7fd7bc994bf3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209975
Listing Expiration 2027-12-31
Marketing Start 2025-12-03

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 21922105
Hyphenated Format 21922-105

Supplemental Identifiers

RxCUI
250344
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 ANDA209975 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 g/100mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (21922-105-52) / 120 mL in 1 BOTTLE
source: ndc

Packages (1)

21922-105-52 1 BOTTLE in 1 CARTON (21922-105-52) / 120 mL in 1 BOTTLE

Ingredients (1)

ciclopirox (1 g/100mL)

Linked Drug Pages (1)

CICLOPIROX ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "1b7b23aa-fc6d-4b37-b5db-7fd7bc994bf3", "openfda": {"nui": ["N0000008577", "N0000008841", "N0000008853", "N0000000150"], "unii": ["19W019ZDRJ"], "rxcui": ["250344"], "spl_set_id": ["cb456f2e-6645-4cc4-8e71-299c47ccb6b7"], "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 in 1 CARTON (21922-105-52)  / 120 mL in 1 BOTTLE", "package_ndc": "21922-105-52", "marketing_start_date": "20251203"}], "brand_name": "CICLOPIROX", "product_id": "21922-105_1b7b23aa-fc6d-4b37-b5db-7fd7bc994bf3", "dosage_form": "SHAMPOO", "pharm_class": ["Decreased DNA Replication [PE]", "Decreased Protein Synthesis [PE]", "Decreased RNA Replication [PE]", "Protein Synthesis Inhibitors [MoA]"], "product_ndc": "21922-105", "generic_name": "ciclopirox", "labeler_name": "Encube Ethicals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CICLOPIROX", "active_ingredients": [{"name": "CICLOPIROX", "strength": "1 g/100mL"}], "application_number": "ANDA209975", "marketing_category": "ANDA", "marketing_start_date": "20251203", "listing_expiration_date": "20271231"}