NDC 66215-201

Zavesca

Miglustat

Zavesca is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Actelion Pharmaceuticals Us, Inc.. The primary component is Miglustat.

• Product ID: 66215-201_009942ad-7392-4bee-b722-663172bc7b60
• NDC: 66215-201
• Product Type: Human Prescription Drug
• Proprietary Name: Zavesca
• Generic Name: Miglustat
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2003-07-31
• Marketing Category: NDA / NDA
• Application Number: NDA021348
• Labeler Name: Actelion Pharmaceuticals US, Inc.
• Substance Name: MIGLUSTAT
• Active Ingredient Strength: 100 mg/1
• Pharm Classes: Glucosylceramide Synthase Inhibitor [EPC],Glucosylceramide Synthase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 66215-201-90

6 BLISTER PACK in 1 CARTON (66215-201-90) > 15 CAPSULE in 1 BLISTER PACK (66215-201-15)

• Marketing Start Date: 2003-07-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 66215-201-15 [66215020115]

Zavesca CAPSULE

• Marketing Category: NDA
• Application Number: NDA021348
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-03-16

NDC 66215-201-90 [66215020190]

Zavesca CAPSULE

• Marketing Category: NDA
• Application Number: NDA021348
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2003-07-31

NDC 66215-201-18 [66215020118]

Zavesca CAPSULE

• Marketing Category: NDA
• Application Number: NDA021348
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2003-07-31
• Marketing End Date: 2016-03-16

Drug Details

Active Ingredients

Ingredient	Strength
MIGLUSTAT	100 mg/1

OpenFDA Data

• SPL SET ID: 817892d1-ee12-4632-85fc-57ccdf16d7b8
• Manufacturer:
  • Actelion Pharmaceuticals US, Inc.
• UNII:
  • ADN3S497AZ
• RxNorm Concept Unique ID - RxCUI:
  • 541070
  • 401938

Pharmacological Class

• Glucosylceramide Synthase Inhibitor [EPC]
• Glucosylceramide Synthase Inhibitors [MoA]

NDC Crossover Matching brand name "Zavesca" or generic name "Miglustat"

NDC	Brand Name	Generic Name
66215-201	Zavesca	miglustat
10148-201	Miglustat	miglustat
42799-708	Miglustat	Miglustat
43975-310	MIGLUSTAT	MIGLUSTAT
51991-959	miglustat	Miglustat