NDC 0168-0313

ciclopirox olamine

Ciclopirox Olamine

ciclopirox olamine is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.. The primary component is Ciclopirox Olamine.

• Product ID: 0168-0313_2c9efbd4-8a94-4331-b8b3-271d3036e2ff
• NDC: 0168-0313
• Product Type: Human Prescription Drug
• Proprietary Name: ciclopirox olamine
• Generic Name: Ciclopirox Olamine
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2004-12-29
• Marketing Category: ANDA / ANDA
• Application Number: ANDA076435
• Labeler Name: E. FOUGERA & CO. A division of Fougera Pharmaceuticals 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: 2018-12-31

Packaging

NDC 0168-0313-90

1 TUBE in 1 CARTON (0168-0313-90) > 90 g in 1 TUBE

• Marketing Start Date: 2004-12-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0168-0313-15 [00168031315]

ciclopirox olamine CREAM

• Marketing Category: ANDA
• Application Number: ANDA076435
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2004-12-29
• Marketing End Date: 2012-11-30

NDC 0168-0313-90 [00168031390]

ciclopirox olamine CREAM

• Marketing Category: ANDA
• Application Number: ANDA076435
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2004-12-29
• Marketing End Date: 2012-11-30

NDC 0168-0313-30 [00168031330]

ciclopirox olamine CREAM

• Marketing Category: ANDA
• Application Number: ANDA076435
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2004-12-29
• Marketing End Date: 2012-09-30

Drug Details

Active Ingredients

Ingredient	Strength
CICLOPIROX OLAMINE	7.7 mg/g

OpenFDA Data

• SPL SET ID: 8bb9fcdf-c0f2-49f5-b5fc-6f4f98581c6a
• Manufacturer:
  • E. FOUGERA & CO. A division of Fougera Pharmaceuticals 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