ciclopirox olamine

Generic: ciclopirox olamine

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ciclopirox olamine
Generic Name ciclopirox olamine
Labeler sun pharmaceutical industries, inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

ciclopirox olamine 7.7 mg/g

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 51672-1318
Product ID 51672-1318_4882ff99-b917-693b-e063-6394a90a4476
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076790
Listing Expiration 2027-12-31
Marketing Start 2005-04-12

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 516721318
Hyphenated Format 51672-1318

Supplemental Identifiers

RxCUI
309289
UPC
0351672131883
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 ANDA076790 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 7.7 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (51672-1318-1) / 15 g in 1 TUBE
  • 1 TUBE in 1 CARTON (51672-1318-2) / 30 g in 1 TUBE
  • 1 TUBE in 1 CARTON (51672-1318-8) / 90 g in 1 TUBE
source: ndc

Packages (3)

51672-1318-1 1 TUBE in 1 CARTON (51672-1318-1) / 15 g in 1 TUBE 51672-1318-2 1 TUBE in 1 CARTON (51672-1318-2) / 30 g in 1 TUBE 51672-1318-8 1 TUBE in 1 CARTON (51672-1318-8) / 90 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": "4882ff99-b917-693b-e063-6394a90a4476", "openfda": {"upc": ["0351672131883"], "unii": ["50MD4SB4AP"], "rxcui": ["309289"], "spl_set_id": ["7fa4032e-a819-4574-b484-c57aaf1c5b01"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (51672-1318-1)  / 15 g in 1 TUBE", "package_ndc": "51672-1318-1", "marketing_start_date": "20050412"}, {"sample": false, "description": "1 TUBE in 1 CARTON (51672-1318-2)  / 30 g in 1 TUBE", "package_ndc": "51672-1318-2", "marketing_start_date": "20050412"}, {"sample": false, "description": "1 TUBE in 1 CARTON (51672-1318-8)  / 90 g in 1 TUBE", "package_ndc": "51672-1318-8", "marketing_start_date": "20050412"}], "brand_name": "Ciclopirox Olamine", "product_id": "51672-1318_4882ff99-b917-693b-e063-6394a90a4476", "dosage_form": "CREAM", "pharm_class": ["Decreased DNA Replication [PE]", "Decreased Protein Synthesis [PE]", "Decreased RNA Replication [PE]", "Protein Synthesis Inhibitors [MoA]"], "product_ndc": "51672-1318", "generic_name": "ciclopirox olamine", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ciclopirox Olamine", "active_ingredients": [{"name": "CICLOPIROX OLAMINE", "strength": "7.7 mg/g"}], "application_number": "ANDA076790", "marketing_category": "ANDA", "marketing_start_date": "20050412", "listing_expiration_date": "20271231"}