NDC 58468-1983

Cerezyme

Imiglucerase

Cerezyme is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Genzyme Corporation. The primary component is Imiglucerase.

• Product ID: 58468-1983_32c3b588-388f-4e22-8fc7-af0f8b992755
• NDC: 58468-1983
• Product Type: Human Prescription Drug
• Proprietary Name: Cerezyme
• Generic Name: Imiglucerase
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 1994-05-23
• Marketing Category: NDA / NDA
• Application Number: NDA020367
• Labeler Name: Genzyme Corporation
• Substance Name: IMIGLUCERASE
• Active Ingredient Strength: 40 U/mL
• Pharm Classes: Glucosylceramidase [CS],Hydrolytic Lysosomal Glucocerebroside-specific Enzyme [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 58468-1983-1

1 VIAL, GLASS in 1 CARTON (58468-1983-1) > 5 mL in 1 VIAL, GLASS

• Marketing Start Date: 1994-05-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58468-1983-1 [58468198301]

Cerezyme INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA020367
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1994-05-23

Drug Details

Active Ingredients

Ingredient	Strength
IMIGLUCERASE	40 U/mL

OpenFDA Data

• SPL SET ID: df60f030-866b-4374-a31f-8ae3f6b45c38
• Manufacturer:
  • Genzyme Corporation
• UNII:
  • Q6U6J48BWY
• RxNorm Concept Unique ID - RxCUI:
  • 1726260
  • 1726257
  • 1726268
  • 1726266

Pharmacological Class

• Glucosylceramidase [CS]
• Hydrolytic Lysosomal Glucocerebroside-specific Enzyme [EPC]

NDC Crossover Matching brand name "Cerezyme" or generic name "Imiglucerase"

NDC	Brand Name	Generic Name
58468-1983	Cerezyme	IMIGLUCERASE
58468-4663	Cerezyme	IMIGLUCERASE