NDC 0682-0051

Crotan

Crotamiton

Crotan is a Topical Lotion in the Human Prescription Drug category. It is labeled and distributed by Marnel Pharmaceuticals, Inc.. The primary component is Crotamiton.

• Product ID: 0682-0051_9d369d3e-fa64-8bf5-e053-2a95a90a1212
• NDC: 0682-0051
• Product Type: Human Prescription Drug
• Proprietary Name: Crotan
• Generic Name: Crotamiton
• Dosage Form: Lotion
• Route of Administration: TOPICAL
• Marketing Start Date: 2018-07-16
• Marketing Category: ANDA / ANDA
• Application Number: ANDA087204
• Labeler Name: Marnel Pharmaceuticals, Inc.
• Substance Name: CROTAMITON
• Active Ingredient Strength: 100 mg/g
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0682-0051-10

237 g in 1 BOTTLE, PLASTIC (0682-0051-10)

• Marketing Start Date: 2018-07-16
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0682-0051-10 [00682005110]

Crotan LOTION

• Marketing Category: ANDA
• Application Number: ANDA087204
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2018-07-16

NDC 0682-0051-30 [00682005130]

Crotan LOTION

• Marketing Category: ANDA
• Application Number: ANDA087204
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2018-08-13

NDC 0682-0051-20 [00682005120]

Crotan LOTION

• Marketing Category: ANDA
• Application Number: ANDA087204
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2018-08-13

Drug Details

Active Ingredients

Ingredient	Strength
CROTAMITON	100 mg/g

OpenFDA Data

• SPL SET ID: 6f7478fa-ed2b-4943-9d40-1fd0161a0854
• Manufacturer:
  • Marnel Pharmaceuticals, Inc.
• UNII:
  • D6S4O4XD0H
• RxNorm Concept Unique ID - RxCUI:
  • 106219
  • 2049603

NDC Crossover Matching brand name "Crotan" or generic name "Crotamiton"

NDC	Brand Name	Generic Name
0682-0051	Crotan	Crotamiton
10631-091	Eurax	crotamiton
10631-092	Eurax	crotamiton