ciclopirox

Generic: ciclopirox

Labeler: padagis israel pharmaceuticals ltd
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ciclopirox
Generic Name ciclopirox
Labeler padagis israel pharmaceuticals ltd
Dosage Form SHAMPOO
Routes
TOPICAL
Active Ingredients

ciclopirox 1 g/100mL

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-401
Product ID 45802-401_f9c45e64-a8ae-4bc5-9d1f-40eac9847c55
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078594
Listing Expiration 2026-12-31
Marketing Start 2010-02-17

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 45802401
Hyphenated Format 45802-401

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 ANDA078594 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 g/100mL
source: ndc
Packaging
  • 120 mL in 1 BOTTLE (45802-401-09)
source: ndc

Packages (1)

45802-401-09 120 mL in 1 BOTTLE (45802-401-09)

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": "f9c45e64-a8ae-4bc5-9d1f-40eac9847c55", "openfda": {"nui": ["N0000008577", "N0000008841", "N0000008853", "N0000000150"], "unii": ["19W019ZDRJ"], "rxcui": ["250344"], "spl_set_id": ["c3722d52-407c-499b-a08b-b299609f203c"], "pharm_class_pe": ["Decreased DNA Replication [PE]", "Decreased Protein Synthesis [PE]", "Decreased RNA Replication [PE]"], "pharm_class_moa": ["Protein Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 mL in 1 BOTTLE (45802-401-09)", "package_ndc": "45802-401-09", "marketing_start_date": "20100217"}], "brand_name": "Ciclopirox", "product_id": "45802-401_f9c45e64-a8ae-4bc5-9d1f-40eac9847c55", "dosage_form": "SHAMPOO", "pharm_class": ["Decreased DNA Replication [PE]", "Decreased Protein Synthesis [PE]", "Decreased RNA Replication [PE]", "Protein Synthesis Inhibitors [MoA]"], "product_ndc": "45802-401", "generic_name": "Ciclopirox", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ciclopirox", "active_ingredients": [{"name": "CICLOPIROX", "strength": "1 g/100mL"}], "application_number": "ANDA078594", "marketing_category": "ANDA", "marketing_start_date": "20100217", "listing_expiration_date": "20261231"}