NDC 0168-0449

Ciclopirox

Ciclopirox

Ciclopirox is a Topical Shampoo in the Human Prescription Drug category. It is labeled and distributed by Fougera Pharmaceuticals Inc.. The primary component is Ciclopirox.

• Product ID: 0168-0449_710704bb-c966-436e-962e-1c317c27269f
• NDC: 0168-0449
• Product Type: Human Prescription Drug
• Proprietary Name: Ciclopirox
• Generic Name: Ciclopirox
• Dosage Form: Shampoo
• Route of Administration: TOPICAL
• Marketing Start Date: 2010-05-25
• Marketing Category: ANDA / ANDA
• Application Number: ANDA090146
• Labeler Name: Fougera Pharmaceuticals Inc.
• Substance Name: CICLOPIROX
• Active Ingredient Strength: 10 mg/.96mL
• 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: 2021-12-31

Packaging

NDC 0168-0449-04

1 BOTTLE in 1 CARTON (0168-0449-04) > 120 mL in 1 BOTTLE

• Marketing Start Date: 2010-05-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0168-0449-04 [00168044904]

Ciclopirox SHAMPOO

• Marketing Category: ANDA
• Application Number: ANDA090146
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2010-05-25
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
CICLOPIROX	10 mg/.96mL

OpenFDA Data

• SPL SET ID: 288a1cb0-ff4c-482c-9f1a-45ea3dbb3b52
• Manufacturer:
  • E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
• UNII:
  • 19W019ZDRJ
• RxNorm Concept Unique ID - RxCUI:
  • 250344
• UPC Code:
  • 0301680449043

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
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
68071-1524	Ciclopirox	Ciclopirox
68071-4412	Ciclopirox	Ciclopirox
68462-455	ciclopirox	ciclopirox
68788-6797	Ciclopirox	Ciclopirox
68788-7138	Ciclopirox	Ciclopirox
68071-4977	Ciclopirox	Ciclopirox
43538-500	Ciclodan	ciclopirox
43538-501	Ciclodan	ciclopirox
0187-5180	Penlac	ciclopirox