ciclopirox olamine

Generic: ciclopirox olamine

Labeler: cosette pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ciclopirox olamine
Generic Name ciclopirox olamine
Labeler cosette pharmaceuticals, inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

ciclopirox olamine 7.7 mg/g

Manufacturer
Cosette Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0713-0638
Product ID 0713-0638_ed9669ad-fa01-5788-e053-2995a90a5897
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078463
Listing Expiration 2026-12-31
Marketing Start 2007-05-22

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 07130638
Hyphenated Format 0713-0638

Supplemental Identifiers

RxCUI
309289
UPC
0307130638159
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 ANDA078463 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 7.7 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 BOX (0713-0638-15) / 15 g in 1 TUBE
  • 1 TUBE in 1 BOX (0713-0638-18) / 90 g in 1 TUBE
  • 1 TUBE in 1 BOX (0713-0638-31) / 30 g in 1 TUBE
source: ndc

Packages (3)

0713-0638-15 1 TUBE in 1 BOX (0713-0638-15) / 15 g in 1 TUBE 0713-0638-18 1 TUBE in 1 BOX (0713-0638-18) / 90 g in 1 TUBE 0713-0638-31 1 TUBE in 1 BOX (0713-0638-31) / 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": "ed9669ad-fa01-5788-e053-2995a90a5897", "openfda": {"upc": ["0307130638159"], "unii": ["50MD4SB4AP"], "rxcui": ["309289"], "spl_set_id": ["5c585aa5-7d2d-e798-c0bd-d602574d643c"], "manufacturer_name": ["Cosette Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 BOX (0713-0638-15)  / 15 g in 1 TUBE", "package_ndc": "0713-0638-15", "marketing_start_date": "20070522"}, {"sample": false, "description": "1 TUBE in 1 BOX (0713-0638-18)  / 90 g in 1 TUBE", "package_ndc": "0713-0638-18", "marketing_start_date": "20070522"}, {"sample": false, "description": "1 TUBE in 1 BOX (0713-0638-31)  / 30 g in 1 TUBE", "package_ndc": "0713-0638-31", "marketing_start_date": "20070522"}], "brand_name": "Ciclopirox Olamine", "product_id": "0713-0638_ed9669ad-fa01-5788-e053-2995a90a5897", "dosage_form": "CREAM", "pharm_class": ["Decreased DNA Replication [PE]", "Decreased Protein Synthesis [PE]", "Decreased RNA Replication [PE]", "Protein Synthesis Inhibitors [MoA]"], "product_ndc": "0713-0638", "generic_name": "Ciclopirox Olamine", "labeler_name": "Cosette Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ciclopirox Olamine", "active_ingredients": [{"name": "CICLOPIROX OLAMINE", "strength": "7.7 mg/g"}], "application_number": "ANDA078463", "marketing_category": "ANDA", "marketing_start_date": "20070522", "listing_expiration_date": "20261231"}