ciclopirox

Generic: ciclopirox

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ciclopirox
Generic Name ciclopirox
Labeler chartwell rx, llc
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

ciclopirox 71.3 mg/mL

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-814
Product ID 62135-814_41b5be9e-4f27-f7aa-e063-6394a90a00d8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078046
Listing Expiration 2026-12-31
Marketing Start 2007-09-18

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 62135814
Hyphenated Format 62135-814

Supplemental Identifiers

UPC
0362135814458
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 ANDA078046 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 71.3 mg/mL
source: ndc
Packaging
  • 6.6 mL in 1 BOTTLE (62135-814-45)
source: ndc

Packages (1)

62135-814-45 6.6 mL in 1 BOTTLE (62135-814-45)

Ingredients (1)

ciclopirox (71.3 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": "41b5be9e-4f27-f7aa-e063-6394a90a00d8", "openfda": {"nui": ["N0000008577", "N0000008841", "N0000008853", "N0000000150"], "upc": ["0362135814458"], "unii": ["19W019ZDRJ"], "spl_set_id": ["8ce98020-5615-4332-bf57-72777e2ce038"], "pharm_class_pe": ["Decreased DNA Replication [PE]", "Decreased Protein Synthesis [PE]", "Decreased RNA Replication [PE]"], "pharm_class_moa": ["Protein Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6.6 mL in 1 BOTTLE (62135-814-45)", "package_ndc": "62135-814-45", "marketing_start_date": "20240328"}], "brand_name": "Ciclopirox", "product_id": "62135-814_41b5be9e-4f27-f7aa-e063-6394a90a00d8", "dosage_form": "SOLUTION", "pharm_class": ["Decreased DNA Replication [PE]", "Decreased Protein Synthesis [PE]", "Decreased RNA Replication [PE]", "Protein Synthesis Inhibitors [MoA]"], "product_ndc": "62135-814", "generic_name": "Ciclopirox", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ciclopirox", "active_ingredients": [{"name": "CICLOPIROX", "strength": "71.3 mg/mL"}], "application_number": "ANDA078046", "marketing_category": "ANDA", "marketing_start_date": "20070918", "listing_expiration_date": "20261231"}