ciclopirox olamine

Generic: ciclopirox olamine

Labeler: padagis israel pharmaceuticals ltd
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ciclopirox olamine
Generic Name ciclopirox olamine
Labeler padagis israel pharmaceuticals ltd
Dosage Form SUSPENSION
Routes
TOPICAL
Active Ingredients

ciclopirox olamine 7.7 mg/100mL

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-400
Product ID 45802-400_ae67550c-f609-40a6-8f0c-8909d360de0b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077676
Listing Expiration 2026-12-31
Marketing Start 2006-12-29

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 45802400
Hyphenated Format 45802-400

Supplemental Identifiers

RxCUI
309290
UNII
50MD4SB4AP

Packaging Origin

Original Packager
true

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 ANDA077676 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 7.7 mg/100mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (45802-400-46) / 60 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (45802-400-49) / 30 mL in 1 BOTTLE
source: ndc

Packages (2)

45802-400-46 1 BOTTLE in 1 CARTON (45802-400-46) / 60 mL in 1 BOTTLE 45802-400-49 1 BOTTLE in 1 CARTON (45802-400-49) / 30 mL in 1 BOTTLE

Ingredients (1)

ciclopirox olamine (7.7 mg/100mL)

Linked Drug Pages (1)

Ciclopirox Olamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "ae67550c-f609-40a6-8f0c-8909d360de0b", "openfda": {"unii": ["50MD4SB4AP"], "rxcui": ["309290"], "spl_set_id": ["eadbd29d-5990-4987-833f-40cd0b2d2868"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (45802-400-46)  / 60 mL in 1 BOTTLE", "package_ndc": "45802-400-46", "marketing_start_date": "20061229"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (45802-400-49)  / 30 mL in 1 BOTTLE", "package_ndc": "45802-400-49", "marketing_start_date": "20061229"}], "brand_name": "Ciclopirox Olamine", "product_id": "45802-400_ae67550c-f609-40a6-8f0c-8909d360de0b", "dosage_form": "SUSPENSION", "pharm_class": ["Decreased DNA Replication [PE]", "Decreased Protein Synthesis [PE]", "Decreased RNA Replication [PE]", "Protein Synthesis Inhibitors [MoA]"], "product_ndc": "45802-400", "generic_name": "Ciclopirox Olamine", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ciclopirox Olamine", "active_ingredients": [{"name": "CICLOPIROX OLAMINE", "strength": "7.7 mg/100mL"}], "application_number": "ANDA077676", "marketing_category": "ANDA", "marketing_start_date": "20061229", "listing_expiration_date": "20261231"}