NDC 0187-5180

Penlac

Ciclopirox

Penlac is a Topical Solution in the Human Prescription Drug category. It is labeled and distributed by Bausch Health Us Llc. The primary component is Ciclopirox.

• Product ID: 0187-5180_50c70e79-72ba-4581-9b50-c710e446bb0a
• NDC: 0187-5180
• Product Type: Human Prescription Drug
• Proprietary Name: Penlac
• Generic Name: Ciclopirox
• Dosage Form: Solution
• Route of Administration: TOPICAL
• Marketing Start Date: 2013-05-01
• Marketing Category: NDA / NDA
• Application Number: NDA021022
• Labeler Name: Bausch Health US LLC
• Substance Name: CICLOPIROX
• Active Ingredient Strength: 80 mg/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: 2021-12-31

Packaging

NDC 0187-5180-06

6.6 mL in 1 BOTTLE, WITH APPLICATOR (0187-5180-06)

• Marketing Start Date: 2013-05-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0187-5180-06 [00187518006]

Penlac SOLUTION

• Marketing Category: NDA
• Application Number: NDA021022
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2013-05-01

Drug Details

Active Ingredients

Ingredient	Strength
CICLOPIROX	80 mg/mL

OpenFDA Data

• SPL SET ID: 9793245c-c3e0-4351-a2ab-b54b46aecb43
• Manufacturer:
  • Valeant Pharmaceuticals North America LLC
• UNII:
  • 19W019ZDRJ
• RxNorm Concept Unique ID - RxCUI:
  • 309291
  • 261345

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0187-5180	Penlac	ciclopirox
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