NDC 68712-027

CNL8

Ciclopirox

CNL8 is a Topical Solution in the Human Prescription Drug category. It is labeled and distributed by Innocutis Holdings Llc. The primary component is Ciclopirox.

• Product ID: 68712-027_b367ac0c-2c88-4c37-809b-da4297a47cc6
• NDC: 68712-027
• Product Type: Human Prescription Drug
• Proprietary Name: CNL8
• Generic Name: Ciclopirox
• Dosage Form: Solution
• Route of Administration: TOPICAL
• Marketing Start Date: 2008-10-31
• Marketing Category: ANDA / ANDA
• Application Number: ANDA078270
• Labeler Name: Innocutis Holdings LLC
• 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: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 68712-027-01

3 BOTTLE, GLASS in 1 CARTON (68712-027-01) > 5 mL in 1 BOTTLE, GLASS (68712-027-03)

• Marketing Start Date: 2008-10-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68712-027-03 [68712002703]

CNL8 SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA078270
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2011-12-16
• Inactivation Date: 2019-11-13

NDC 68712-027-01 [68712002701]

CNL8 SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA078270
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2008-10-31
• Inactivation Date: 2019-11-13

Drug Details

Active Ingredients

Ingredient	Strength
CICLOPIROX	2.28 g/mL

OpenFDA Data

• SPL SET ID: 68955ba2-590f-4460-994e-bc481aed3d23
• Manufacturer:
  • Innocutis Holdings LLC
• UNII:
  • 19W019ZDRJ
• RxNorm Concept Unique ID - RxCUI:
  • 309291
  • 847217

Pharmacological Class

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

NDC Crossover Matching brand name "CNL8" or generic name "Ciclopirox"

NDC	Brand Name	Generic Name
68712-027	CNL8	CNL8
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