ciclopirox olamine

Generic: ciclopirox olamine

Labeler: advanced rx pharmacy of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ciclopirox olamine
Generic Name ciclopirox olamine
Labeler advanced rx pharmacy of tennessee, llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

ciclopirox olamine 7.7 mg/g

Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0225
Product ID 80425-0225_2a9b7c00-167c-4da0-e063-6394a90a926d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090273
Listing Expiration 2026-12-31
Marketing Start 2023-01-09

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 804250225
Hyphenated Format 80425-0225

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 ANDA090273 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 7.7 mg/g
source: ndc
Packaging
  • 30 g in 1 CARTON (80425-0225-1)
source: ndc

Packages (1)

80425-0225-1 30 g in 1 CARTON (80425-0225-1)

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": "2a9b7c00-167c-4da0-e063-6394a90a926d", "openfda": {"unii": ["50MD4SB4AP"], "rxcui": ["309289"], "spl_set_id": ["f186e394-7390-4b8a-e053-2a95a90abed1"], "manufacturer_name": ["Advanced Rx Pharmacy of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 g in 1 CARTON (80425-0225-1)", "package_ndc": "80425-0225-1", "marketing_start_date": "20230109"}], "brand_name": "Ciclopirox Olamine", "product_id": "80425-0225_2a9b7c00-167c-4da0-e063-6394a90a926d", "dosage_form": "CREAM", "pharm_class": ["Decreased DNA Replication [PE]", "Decreased Protein Synthesis [PE]", "Decreased RNA Replication [PE]", "Protein Synthesis Inhibitors [MoA]"], "product_ndc": "80425-0225", "generic_name": "Ciclopirox Olamine", "labeler_name": "Advanced Rx Pharmacy of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ciclopirox Olamine", "active_ingredients": [{"name": "CICLOPIROX OLAMINE", "strength": "7.7 mg/g"}], "application_number": "ANDA090273", "marketing_category": "ANDA", "marketing_start_date": "20230109", "listing_expiration_date": "20261231"}