NDC 68258-3996

Ciclopirox Olamine

Ciclopirox Olamine

Ciclopirox Olamine is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Dispensing Solutions, Inc.. The primary component is Ciclopirox Olamine.

• Product ID: 68258-3996_6b02cebe-eea9-464f-88eb-7c9db13b79fc
• NDC: 68258-3996
• Product Type: Human Prescription Drug
• Proprietary Name: Ciclopirox Olamine
• Generic Name: Ciclopirox Olamine
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2009-11-13
• Marketing Category: ANDA / ANDA
• Application Number: ANDA090273
• Labeler Name: Dispensing Solutions, Inc.
• Substance Name: CICLOPIROX OLAMINE
• Active Ingredient Strength: 8 mg/g
• 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 68258-3996-3

30 g in 1 CARTON (68258-3996-3)

• Marketing Start Date: 2009-11-13
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68258-3996-3 [68258399603]

Ciclopirox Olamine CREAM

• Marketing Category: ANDA
• Application Number: ANDA090273
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-11-13
• Inactivation Date: 2019-11-27

Drug Details

Active Ingredients

Ingredient	Strength
CICLOPIROX OLAMINE	7.7 mg/g

OpenFDA Data

• SPL SET ID: 9982d093-9f17-48de-8d06-b8256a20c764
• Manufacturer:
  • Dispensing Solutions, Inc.
• UNII:
  • 50MD4SB4AP
• RxNorm Concept Unique ID - RxCUI:
  • 309289

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0168-0313	ciclopirox olamine	ciclopirox olamine
0713-0638	Ciclopirox Olamine	Ciclopirox Olamine
45802-138	Ciclopirox Olamine	Ciclopirox Olamine
45802-400	Ciclopirox Olamine	Ciclopirox Olamine
49999-646	CICLOPIROX OLAMINE	CICLOPIROX OLAMINE
51672-1318	Ciclopirox Olamine	ciclopirox olamine
53002-9450	Ciclopirox Olamine	ciclopirox olamine
63629-2522	Ciclopirox Olamine	Ciclopirox Olamine
63629-8624	Ciclopirox Olamine	Ciclopirox Olamine
63629-8625	Ciclopirox Olamine	Ciclopirox Olamine
63629-8626	Ciclopirox Olamine	Ciclopirox Olamine
63629-8627	Ciclopirox Olamine	Ciclopirox Olamine
68071-1608	Ciclopirox Olamine	Ciclopirox Olamine
68071-4162	Ciclopirox Olamine	ciclopirox olamine
68258-3996	Ciclopirox Olamine	Ciclopirox Olamine
68462-297	Ciclopirox Olamine	Ciclopirox Olamine
69315-309	CICLOPIROX OLAMINE	CICLOPIROX OLAMINE
80425-0225	Ciclopirox Olamine	Ciclopirox Olamine
43538-540	Loprox	ciclopirox olamine
43538-541	Loprox	Ciclopirox Olamine
43538-550	Loprox	ciclopirox olamine
43538-551	Loprox	Ciclopirox Olamine