ciclopirox

Generic: ciclopirox

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ciclopirox
Generic Name ciclopirox
Labeler actavis pharma, inc.
Dosage Form SHAMPOO
Routes
TOPICAL
Active Ingredients

ciclopirox 10 mg/.96mL

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0591-2159
Product ID 0591-2159_7c6bdb3d-4717-429d-9632-3f64d7aa2e80
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090490
Listing Expiration 2026-12-31
Marketing Start 2012-12-12

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 05912159
Hyphenated Format 0591-2159

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 ANDA090490 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/.96mL
source: ndc
Packaging
  • 120 mL in 1 BOTTLE, PLASTIC (0591-2159-90)
source: ndc

Packages (1)

0591-2159-90 120 mL in 1 BOTTLE, PLASTIC (0591-2159-90)

Ingredients (1)

ciclopirox (10 mg/.96mL)

Linked Drug Pages (1)

Ciclopirox ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "7c6bdb3d-4717-429d-9632-3f64d7aa2e80", "openfda": {"nui": ["N0000008577", "N0000008841", "N0000008853", "N0000000150"], "unii": ["19W019ZDRJ"], "rxcui": ["250344"], "spl_set_id": ["eef13684-751f-47e1-b75e-3401a0e6e20f"], "pharm_class_pe": ["Decreased DNA Replication [PE]", "Decreased Protein Synthesis [PE]", "Decreased RNA Replication [PE]"], "pharm_class_moa": ["Protein Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 mL in 1 BOTTLE, PLASTIC (0591-2159-90)", "package_ndc": "0591-2159-90", "marketing_start_date": "20121212"}], "brand_name": "Ciclopirox", "product_id": "0591-2159_7c6bdb3d-4717-429d-9632-3f64d7aa2e80", "dosage_form": "SHAMPOO", "pharm_class": ["Decreased DNA Replication [PE]", "Decreased Protein Synthesis [PE]", "Decreased RNA Replication [PE]", "Protein Synthesis Inhibitors [MoA]"], "product_ndc": "0591-2159", "generic_name": "Ciclopirox", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ciclopirox", "active_ingredients": [{"name": "CICLOPIROX", "strength": "10 mg/.96mL"}], "application_number": "ANDA090490", "marketing_category": "ANDA", "marketing_start_date": "20121212", "listing_expiration_date": "20261231"}