ciclopirox olamine

Generic: ciclopirox olamine

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

Drug Facts

Product Profile

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

ciclopirox olamine 7.7 mg/g

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-8625
Product ID 63629-8625_cdc411f9-07e8-4bd7-ab52-526bee8241e6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077364
Listing Expiration 2026-12-31
Marketing Start 2006-07-19

Pharmacologic Class

Classes
decreased dna replication [pe] decreased protein synthesis [pe] decreased rna replication [pe] protein synthesis inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 636298625
Hyphenated Format 63629-8625

Supplemental Identifiers

RxCUI
309289
UNII
50MD4SB4AP

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 olamine (source: ndc)
Generic Name ciclopirox olamine (source: ndc)
Application Number ANDA077364 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 7.7 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (63629-8625-1) / 30 g in 1 TUBE
source: ndc

Packages (1)

63629-8625-1 1 TUBE in 1 CARTON (63629-8625-1) / 30 g in 1 TUBE

Ingredients (1)

ciclopirox olamine (7.7 mg/g)

Linked Drug Pages (1)

Ciclopirox Olamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "cdc411f9-07e8-4bd7-ab52-526bee8241e6", "openfda": {"unii": ["50MD4SB4AP"], "rxcui": ["309289"], "spl_set_id": ["aa326ade-ff55-4355-b6c7-205d6d88d0a3"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (63629-8625-1)  / 30 g in 1 TUBE", "package_ndc": "63629-8625-1", "marketing_start_date": "20060719"}], "brand_name": "Ciclopirox Olamine", "product_id": "63629-8625_cdc411f9-07e8-4bd7-ab52-526bee8241e6", "dosage_form": "CREAM", "pharm_class": ["Decreased DNA Replication [PE]", "Decreased Protein Synthesis [PE]", "Decreased RNA Replication [PE]", "Protein Synthesis Inhibitors [MoA]"], "product_ndc": "63629-8625", "generic_name": "Ciclopirox Olamine", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ciclopirox Olamine", "active_ingredients": [{"name": "CICLOPIROX OLAMINE", "strength": "7.7 mg/g"}], "application_number": "ANDA077364", "marketing_category": "ANDA", "marketing_start_date": "20060719", "listing_expiration_date": "20261231"}