NDC 0713-0638

Ciclopirox Olamine

Ciclopirox Olamine

Ciclopirox Olamine is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by G&w Laboratories, Inc.. The primary component is Ciclopirox Olamine.

• Product ID: 0713-0638_016fc036-89b0-4c3b-865a-ac5d4656fc6d
• NDC: 0713-0638
• Product Type: Human Prescription Drug
• Proprietary Name: Ciclopirox Olamine
• Generic Name: Ciclopirox Olamine
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2007-05-22
• Marketing Category: ANDA / ANDA
• Application Number: ANDA078463
• Labeler Name: G&W Laboratories, 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: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0713-0638-15

1 TUBE in 1 BOX (0713-0638-15) > 15 g in 1 TUBE

• Marketing Start Date: 2007-05-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0713-0638-18 [00713063818]

Ciclopirox Olamine CREAM

• Marketing Category: ANDA
• Application Number: ANDA078463
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2007-05-22

NDC 0713-0638-31 [00713063831]

Ciclopirox Olamine CREAM

• Marketing Category: ANDA
• Application Number: ANDA078463
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2007-05-22

NDC 0713-0638-15 [00713063815]

Ciclopirox Olamine CREAM

• Marketing Category: ANDA
• Application Number: ANDA078463
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2007-05-22

Drug Details

Active Ingredients

Ingredient	Strength
CICLOPIROX OLAMINE	7.7 mg/g

OpenFDA Data

• SPL SET ID: 5c585aa5-7d2d-e798-c0bd-d602574d643c
• Manufacturer:
  • G&W Laboratories, 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