NDC 54092-700

ELAPRASE

Idursulfase

ELAPRASE is a Intravenous Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Takeda Pharmaceuticals America, Inc.. The primary component is Idursulfase.

• Product ID: 54092-700_22b76b84-ac55-42f6-ad5a-de64f6f890db
• NDC: 54092-700
• Product Type: Human Prescription Drug
• Proprietary Name: ELAPRASE
• Generic Name: Idursulfase
• Dosage Form: Solution, Concentrate
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2006-07-24
• Marketing Category: BLA / BLA
• Application Number: BLA125151
• Labeler Name: Takeda Pharmaceuticals America, Inc.
• Substance Name: IDURSULFASE
• Active Ingredient Strength: 6 mg/3mL
• Pharm Classes: Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme [EPC], alpha-Glucosidases [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 54092-700-01

1 VIAL, GLASS in 1 BOX (54092-700-01) > 3 mL in 1 VIAL, GLASS

• Marketing Start Date: 2006-07-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 54092-700-01 [54092070001]

ELAPRASE SOLUTION, CONCENTRATE

• Marketing Category: BLA
• Application Number: BLA125151
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2006-07-24

Drug Details

Active Ingredients

Ingredient	Strength
IDURSULFASE	6 mg/3mL

OpenFDA Data

• SPL SET ID: 60cba843-5aab-4dd7-96dc-66648d413be3
• Manufacturer:
  • Shire US Manufacturing Inc.
• UNII:
  • 5W8JGG2651
• RxNorm Concept Unique ID - RxCUI:
  • 644104
  • 647118

Pharmacological Class

• alpha-Glucosidases [CS]
• Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme [EPC]
• alpha-Glucosidases [CS]
• Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme [EPC]