ciclopirox

Generic: ciclopirox

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ciclopirox
Generic Name ciclopirox
Labeler a-s medication solutions
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

ciclopirox 80 mg/mL

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-6562
Product ID 50090-6562_68e187e9-f915-4585-bfcc-c78fb13cd75f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078172
Listing Expiration 2026-12-31
Marketing Start 2019-11-04

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 500906562
Hyphenated Format 50090-6562

Supplemental Identifiers

RxCUI
309291
UNII
19W019ZDRJ
NUI
N0000008577 N0000008841 N0000008853 N0000000150

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 ANDA078172 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (50090-6562-0) / 6.6 mL in 1 BOTTLE
source: ndc

Packages (1)

50090-6562-0 1 BOTTLE in 1 CARTON (50090-6562-0) / 6.6 mL in 1 BOTTLE

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": "68e187e9-f915-4585-bfcc-c78fb13cd75f", "openfda": {"nui": ["N0000008577", "N0000008841", "N0000008853", "N0000000150"], "unii": ["19W019ZDRJ"], "rxcui": ["309291"], "spl_set_id": ["b281493f-ce8c-42f8-95c7-2eb1c9712157"], "pharm_class_pe": ["Decreased DNA Replication [PE]", "Decreased Protein Synthesis [PE]", "Decreased RNA Replication [PE]"], "pharm_class_moa": ["Protein Synthesis Inhibitors [MoA]"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (50090-6562-0)  / 6.6 mL in 1 BOTTLE", "package_ndc": "50090-6562-0", "marketing_start_date": "20230718"}], "brand_name": "Ciclopirox", "product_id": "50090-6562_68e187e9-f915-4585-bfcc-c78fb13cd75f", "dosage_form": "SOLUTION", "pharm_class": ["Decreased DNA Replication [PE]", "Decreased Protein Synthesis [PE]", "Decreased RNA Replication [PE]", "Protein Synthesis Inhibitors [MoA]"], "product_ndc": "50090-6562", "generic_name": "Ciclopirox", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ciclopirox", "active_ingredients": [{"name": "CICLOPIROX", "strength": "80 mg/mL"}], "application_number": "ANDA078172", "marketing_category": "ANDA", "marketing_start_date": "20191104", "listing_expiration_date": "20261231"}