NDC 0069-0106

ELELYSO

Taliglucerase Alfa

ELELYSO is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Pfizer Laboratories Div Pfizer Inc. The primary component is Taliglucerase Alfa.

• Product ID: 0069-0106_31feb093-b4ad-4615-bef5-5d256052eaac
• NDC: 0069-0106
• Product Type: Human Prescription Drug
• Proprietary Name: ELELYSO
• Generic Name: Taliglucerase Alfa
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2012-05-01
• Marketing Category: BLA / NDA
• Application Number: BLA022458
• Labeler Name: Pfizer Laboratories Div Pfizer Inc
• Substance Name: TALIGLUCERASE ALFA
• Active Ingredient Strength: 200 U/5mL
• Pharm Classes: Glucosylceramidase [CS], Hydrolytic Lysosomal Glucocerebroside-specific Enzyme [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0069-0106-01

1 VIAL, GLASS in 1 CARTON (0069-0106-01) > 5 mL in 1 VIAL, GLASS

• Marketing Start Date: 2012-05-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0069-0106-01 [00069010601]

ELELYSO INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA022458
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-05-01

Drug Details

Active Ingredients

Ingredient	Strength
TALIGLUCERASE ALFA	200 U/5mL

OpenFDA Data

• SPL SET ID: fa3cbd5d-677c-4b19-9032-d9182cb69a83
• Manufacturer:
  • Pfizer Laboratories Div Pfizer Inc
• UNII:
  • 0R4NLX88O4
• RxNorm Concept Unique ID - RxCUI:
  • 1292881
  • 1292879

Pharmacological Class

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