ciclopirox

Generic: ciclopirox

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ciclopirox
Generic Name ciclopirox
Labeler preferred pharmaceuticals inc.
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

ciclopirox 80 mg/mL

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8755
Product ID 68788-8755_d3c4c98c-1054-4e76-b9b6-1bc37acbbc72
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077687
Listing Expiration 2027-12-31
Marketing Start 2024-10-14

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 687888755
Hyphenated Format 68788-8755

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 ANDA077687 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, WITH APPLICATOR in 1 CARTON (68788-8755-6) / 6.6 mL in 1 BOTTLE, WITH APPLICATOR
source: ndc

Packages (1)

68788-8755-6 1 BOTTLE, WITH APPLICATOR in 1 CARTON (68788-8755-6) / 6.6 mL in 1 BOTTLE, WITH APPLICATOR

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": "d3c4c98c-1054-4e76-b9b6-1bc37acbbc72", "openfda": {"nui": ["N0000008577", "N0000008841", "N0000008853", "N0000000150"], "unii": ["19W019ZDRJ"], "rxcui": ["309291"], "spl_set_id": ["eb7b7163-2ee7-447a-b585-7a240070f84b"], "pharm_class_pe": ["Decreased DNA Replication [PE]", "Decreased Protein Synthesis [PE]", "Decreased RNA Replication [PE]"], "pharm_class_moa": ["Protein Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, WITH APPLICATOR in 1 CARTON (68788-8755-6)  / 6.6 mL in 1 BOTTLE, WITH APPLICATOR", "package_ndc": "68788-8755-6", "marketing_start_date": "20241014"}], "brand_name": "CICLOPIROX", "product_id": "68788-8755_d3c4c98c-1054-4e76-b9b6-1bc37acbbc72", "dosage_form": "SOLUTION", "pharm_class": ["Decreased DNA Replication [PE]", "Decreased Protein Synthesis [PE]", "Decreased RNA Replication [PE]", "Protein Synthesis Inhibitors [MoA]"], "product_ndc": "68788-8755", "generic_name": "ciclopirox", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CICLOPIROX", "active_ingredients": [{"name": "CICLOPIROX", "strength": "80 mg/mL"}], "application_number": "ANDA077687", "marketing_category": "ANDA", "marketing_start_date": "20241014", "listing_expiration_date": "20271231"}