NDC 49999-646

CICLOPIROX OLAMINE

Ciclopirox Olamine

CICLOPIROX OLAMINE is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Lake Erie Medical Dba Quality Care Products Llc. The primary component is Ciclopirox Olamine.

• Product ID: 49999-646_fce94d1c-69de-4bfa-854e-d08a2de7327e
• NDC: 49999-646
• Product Type: Human Prescription Drug
• Proprietary Name: CICLOPIROX OLAMINE
• Generic Name: Ciclopirox Olamine
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2010-11-03
• Marketing Category: ANDA / ANDA
• Application Number: ANDA077364
• Labeler Name: Lake Erie Medical DBA Quality Care Products LLC
• 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 49999-646-15

15 g in 1 TUBE (49999-646-15)

• Marketing Start Date: 2010-11-03
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 49999-646-15 [49999064615]

CICLOPIROX OLAMINE CREAM

• Marketing Category: ANDA
• Application Number: ANDA077364
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2010-11-03
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
CICLOPIROX OLAMINE	7.7 mg/g

OpenFDA Data

• SPL SET ID: 9a6adda7-5827-4731-b518-ee2ec1b90cdb
• Manufacturer:
  • Lake Erie Medical DBA Quality Care Products LLC
• 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