NDC 43538-501

Ciclodan

Ciclopirox

Ciclodan is a Topical Solution in the Human Prescription Drug category. It is labeled and distributed by Medimetriks Pharmaceuticals, Inc.. The primary component is Ciclopirox.

• Product ID: 43538-501_a9fcad60-9d86-46a1-858a-3c6aceb3084e
• NDC: 43538-501
• Product Type: Human Prescription Drug
• Proprietary Name: Ciclodan
• Generic Name: Ciclopirox
• Dosage Form: Solution
• Route of Administration: TOPICAL
• Marketing Start Date: 2011-04-10
• Marketing Category: ANDA / ANDA
• Application Number: ANDA078233
• Labeler Name: Medimetriks Pharmaceuticals, Inc.
• Substance Name: CICLOPIROX
• Active Ingredient Strength: 2 g/mL
• Pharm Classes: Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 43538-501-06

1 BOTTLE, WITH APPLICATOR in 1 KIT (43538-501-06) > 6.6 mL in 1 BOTTLE, WITH APPLICATOR

• Marketing Start Date: 2011-04-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 43538-501-06 [43538050106]

Ciclodan SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA078233
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2011-04-10
• Marketing End Date: 2019-11-11

Drug Details

Active Ingredients

Ingredient	Strength
CICLOPIROX	2.28 g/mL

OpenFDA Data

• SPL SET ID: 246676e5-60a0-41dc-b665-30d5e670b426
• Manufacturer:
  • Medimetriks Pharmaceuticals, Inc.
• UNII:
  • 19W019ZDRJ
• RxNorm Concept Unique ID - RxCUI:
  • 309291
  • 1100057
• UPC Code:
  • 0343538500063

Pharmacological Class

• Decreased DNA Replication [PE]
• Decreased Protein Synthesis [PE]
• Decreased RNA Replication [PE]
• Protein Synthesis Inhibitors [MoA]

NDC Crossover Matching brand name "Ciclodan" or generic name "Ciclopirox"

NDC	Brand Name	Generic Name
43538-500	Ciclodan	ciclopirox
43538-501	Ciclodan	ciclopirox
0168-0314	Ciclopirox	ciclopirox
0168-0407	Ciclopirox	Ciclopirox
0168-0449	Ciclopirox	Ciclopirox
0168-0522	Ciclopirox	ciclopirox
0574-2061	CICLOPIROX	CICLOPIROX
0591-2159	Ciclopirox	Ciclopirox
0713-0317	Ciclopirox	CICLOPIROX
21695-475	Ciclopirox	Ciclopirox
42192-714	Ciclopirox	Ciclopirox
42192-715	Ciclopirox	Ciclopirox
45802-141	Ciclopirox	Ciclopirox
45802-401	Ciclopirox	Ciclopirox
47781-530	Ciclopirox	Ciclopirox
50383-419	Ciclopirox	Ciclopirox
51672-1323	Ciclopirox	Ciclopirox
51672-1351	Ciclopirox	ciclopirox
51672-5302	Ciclopirox	ciclopirox
52565-032	Ciclopirox	ciclopirox
61360-1351	Ciclopirox	ciclopirox
61748-200	CICLOPIROX	CICLOPIROX
63629-8620	CICLOPIROX	CICLOPIROX
0187-5180	Penlac	ciclopirox