NDC 58468-0220

Cerdelga

Eliglustat

Cerdelga is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Genzyme Corporation. The primary component is Eliglustat.

• Product ID: 58468-0220_266cc4ac-c972-4a51-a629-314083ddfae6
• NDC: 58468-0220
• Product Type: Human Prescription Drug
• Proprietary Name: Cerdelga
• Generic Name: Eliglustat
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2014-09-03
• Marketing Category: NDA / NDA
• Application Number: NDA205494
• Labeler Name: Genzyme Corporation
• Substance Name: ELIGLUSTAT
• Active Ingredient Strength: 84 mg/1
• Pharm Classes: Glucosylceramide Synthase Inhibitor [EPC],Glucosylceramide Synthase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 58468-0220-1

4 BLISTER PACK in 1 CARTON (58468-0220-1) > 14 CAPSULE in 1 BLISTER PACK

• Marketing Start Date: 2014-09-03
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58468-0220-2 [58468022002]

Cerdelga CAPSULE

• Marketing Category: NDA
• Application Number: NDA205494
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-09-03

NDC 58468-0220-1 [58468022001]

Cerdelga CAPSULE

• Marketing Category: NDA
• Application Number: NDA205494
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-09-03

Drug Details

Active Ingredients

Ingredient	Strength
ELIGLUSTAT	84 mg/1

OpenFDA Data

• SPL SET ID: 819f828a-b888-4e46-83fc-94d774a28a83
• Manufacturer:
  • Genzyme Corporation
• UNII:
  • DR40J4WA67
• RxNorm Concept Unique ID - RxCUI:
  • 1547231
  • 1547225

Pharmacological Class

• Glucosylceramide Synthase Inhibitor [EPC]
• Glucosylceramide Synthase Inhibitors [MoA]
• P-Glycoprotein Inhibitors [MoA]
• Cytochrome P450 2D6 Inhibitors [MoA]