ciclopirox

Generic: ciclopirox

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ciclopirox
Generic Name ciclopirox
Labeler bryant ranch prepack
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

ciclopirox 7.7 mg/g

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-8622
Product ID 63629-8622_52d76980-71dc-4e9d-aeea-1a101eef6b3c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078266
Listing Expiration 2026-12-31
Marketing Start 2009-01-07

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 636298622
Hyphenated Format 63629-8622

Supplemental Identifiers

RxCUI
313941
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 ANDA078266 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 7.7 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (63629-8622-1) / 100 g in 1 TUBE
source: ndc

Packages (1)

63629-8622-1 1 TUBE in 1 CARTON (63629-8622-1) / 100 g in 1 TUBE

Ingredients (1)

ciclopirox (7.7 mg/g)

Linked Drug Pages (1)

CICLOPIROX ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "52d76980-71dc-4e9d-aeea-1a101eef6b3c", "openfda": {"nui": ["N0000008577", "N0000008841", "N0000008853", "N0000000150"], "unii": ["19W019ZDRJ"], "rxcui": ["313941"], "spl_set_id": ["808733e7-9402-4f9b-99ce-ca6d04ad4aee"], "pharm_class_pe": ["Decreased DNA Replication [PE]", "Decreased Protein Synthesis [PE]", "Decreased RNA Replication [PE]"], "pharm_class_moa": ["Protein Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (63629-8622-1)  / 100 g in 1 TUBE", "package_ndc": "63629-8622-1", "marketing_start_date": "20090107"}], "brand_name": "CICLOPIROX", "product_id": "63629-8622_52d76980-71dc-4e9d-aeea-1a101eef6b3c", "dosage_form": "GEL", "pharm_class": ["Decreased DNA Replication [PE]", "Decreased Protein Synthesis [PE]", "Decreased RNA Replication [PE]", "Protein Synthesis Inhibitors [MoA]"], "product_ndc": "63629-8622", "generic_name": "CICLOPIROX", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CICLOPIROX", "active_ingredients": [{"name": "CICLOPIROX", "strength": "7.7 mg/g"}], "application_number": "ANDA078266", "marketing_category": "ANDA", "marketing_start_date": "20090107", "listing_expiration_date": "20261231"}