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 CREAM
Routes
TOPICAL
Active Ingredients

ciclopirox olamine 7.7 mg/g

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-138
Product ID 45802-138_fc4110cb-f2c4-4f48-8038-023def2c825e
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 45802138
Hyphenated Format 45802-138

Supplemental Identifiers

RxCUI
309289
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 ANDA077364 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 7.7 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (45802-138-11) / 30 g in 1 TUBE
  • 1 TUBE in 1 CARTON (45802-138-18) / 90 g in 1 TUBE
  • 1 TUBE in 1 CARTON (45802-138-35) / 15 g in 1 TUBE
source: ndc

Packages (3)

45802-138-11 1 TUBE in 1 CARTON (45802-138-11) / 30 g in 1 TUBE 45802-138-18 1 TUBE in 1 CARTON (45802-138-18) / 90 g in 1 TUBE 45802-138-35 1 TUBE in 1 CARTON (45802-138-35) / 15 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": "fc4110cb-f2c4-4f48-8038-023def2c825e", "openfda": {"unii": ["50MD4SB4AP"], "rxcui": ["309289"], "spl_set_id": ["1a74ed86-997a-4b86-b54a-b2b2c94e8abb"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (45802-138-11)  / 30 g in 1 TUBE", "package_ndc": "45802-138-11", "marketing_start_date": "20060719"}, {"sample": false, "description": "1 TUBE in 1 CARTON (45802-138-18)  / 90 g in 1 TUBE", "package_ndc": "45802-138-18", "marketing_start_date": "20061214"}, {"sample": false, "description": "1 TUBE in 1 CARTON (45802-138-35)  / 15 g in 1 TUBE", "package_ndc": "45802-138-35", "marketing_start_date": "20060905"}], "brand_name": "Ciclopirox olamine", "product_id": "45802-138_fc4110cb-f2c4-4f48-8038-023def2c825e", "dosage_form": "CREAM", "pharm_class": ["Decreased DNA Replication [PE]", "Decreased Protein Synthesis [PE]", "Decreased RNA Replication [PE]", "Protein Synthesis Inhibitors [MoA]"], "product_ndc": "45802-138", "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/g"}], "application_number": "ANDA077364", "marketing_category": "ANDA", "marketing_start_date": "20060719", "listing_expiration_date": "20261231"}