ciclopirox olamine

Generic: ciclopirox olamine

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

Drug Facts

Product Profile

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

ciclopirox olamine 7.7 mg/g

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-297
Product ID 68462-297_740c1d91-06c1-4508-9e94-e5308bec9be3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090273
Listing Expiration 2027-12-31
Marketing Start 2009-11-13

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 68462297
Hyphenated Format 68462-297

Supplemental Identifiers

RxCUI
309289
UPC
0368462297353
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 ANDA090273 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 7.7 mg/g
source: ndc
Packaging
  • 15 g in 1 CARTON (68462-297-17)
  • 30 g in 1 CARTON (68462-297-35)
  • 90 g in 1 CARTON (68462-297-92)
source: ndc

Packages (3)

68462-297-17 15 g in 1 CARTON (68462-297-17) 68462-297-35 30 g in 1 CARTON (68462-297-35) 68462-297-92 90 g in 1 CARTON (68462-297-92)

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": "740c1d91-06c1-4508-9e94-e5308bec9be3", "openfda": {"upc": ["0368462297353"], "unii": ["50MD4SB4AP"], "rxcui": ["309289"], "spl_set_id": ["7385cf42-9f80-4542-8e0f-a0228aa9b43a"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "15 g in 1 CARTON (68462-297-17)", "package_ndc": "68462-297-17", "marketing_start_date": "20091113"}, {"sample": false, "description": "30 g in 1 CARTON (68462-297-35)", "package_ndc": "68462-297-35", "marketing_start_date": "20091113"}, {"sample": false, "description": "90 g in 1 CARTON (68462-297-92)", "package_ndc": "68462-297-92", "marketing_start_date": "20091113"}], "brand_name": "Ciclopirox Olamine", "product_id": "68462-297_740c1d91-06c1-4508-9e94-e5308bec9be3", "dosage_form": "CREAM", "pharm_class": ["Decreased DNA Replication [PE]", "Decreased Protein Synthesis [PE]", "Decreased RNA Replication [PE]", "Protein Synthesis Inhibitors [MoA]"], "product_ndc": "68462-297", "generic_name": "Ciclopirox Olamine", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "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": "20091113", "listing_expiration_date": "20271231"}