ciclopirox

Generic: ciclopirox

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

Drug Facts

Product Profile

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

ciclopirox 7.7 mg/g

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-455
Product ID 68462-455_941ab9d0-0c94-48f9-a8d2-8f164b050a6c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091595
Listing Expiration 2027-12-31
Marketing Start 2012-02-29

Pharmacologic Class

Mechanism of Action
protein synthesis inhibitors [moa]
Physiologic Effect
decreased dna replication [pe] decreased protein synthesis [pe] decreased rna replication [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68462455
Hyphenated Format 68462-455

Supplemental Identifiers

RxCUI
313941
UPC
0368462455357
UNII
19W019ZDRJ
NUI
N0000008577 N0000008841 N0000008853 N0000000150

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 (source: ndc)
Generic Name ciclopirox (source: ndc)
Application Number ANDA091595 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 7.7 mg/g
source: ndc
Packaging
  • 30 g in 1 TUBE (68462-455-35)
  • 45 g in 1 TUBE (68462-455-47)
  • 100 g in 1 TUBE (68462-455-94)
source: ndc

Packages (3)

68462-455-35 30 g in 1 TUBE (68462-455-35) 68462-455-47 45 g in 1 TUBE (68462-455-47) 68462-455-94 100 g in 1 TUBE (68462-455-94)

Ingredients (1)

ciclopirox (7.7 mg/g)

Linked Drug Pages (1)

ciclopirox ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "941ab9d0-0c94-48f9-a8d2-8f164b050a6c", "openfda": {"nui": ["N0000008577", "N0000008841", "N0000008853", "N0000000150"], "upc": ["0368462455357"], "unii": ["19W019ZDRJ"], "rxcui": ["313941"], "spl_set_id": ["3c22416e-4293-4ba5-a983-137cbc6022db"], "pharm_class_pe": ["Decreased DNA Replication [PE]", "Decreased Protein Synthesis [PE]", "Decreased RNA Replication [PE]"], "pharm_class_moa": ["Protein Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 g in 1 TUBE (68462-455-35)", "package_ndc": "68462-455-35", "marketing_start_date": "20120229"}, {"sample": false, "description": "45 g in 1 TUBE (68462-455-47)", "package_ndc": "68462-455-47", "marketing_start_date": "20120229"}, {"sample": false, "description": "100 g in 1 TUBE (68462-455-94)", "package_ndc": "68462-455-94", "marketing_start_date": "20120229"}], "brand_name": "ciclopirox", "product_id": "68462-455_941ab9d0-0c94-48f9-a8d2-8f164b050a6c", "dosage_form": "GEL", "pharm_class": ["Decreased DNA Replication [PE]", "Decreased Protein Synthesis [PE]", "Decreased RNA Replication [PE]", "Protein Synthesis Inhibitors [MoA]"], "product_ndc": "68462-455", "generic_name": "ciclopirox", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ciclopirox", "active_ingredients": [{"name": "CICLOPIROX", "strength": "7.7 mg/g"}], "application_number": "ANDA091595", "marketing_category": "ANDA", "marketing_start_date": "20120229", "listing_expiration_date": "20271231"}