NDC 50090-4534

HYLENEX Recombinant

Hyaluronidase (human Recombinant)

HYLENEX Recombinant is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by A-s Medication Solutions. The primary component is Hyaluronidase (human Recombinant).

• Product ID: 50090-4534_022f7985-c63d-40b2-941b-760a1590ee9c
• NDC: 50090-4534
• Product Type: Human Prescription Drug
• Proprietary Name: HYLENEX Recombinant
• Generic Name: Hyaluronidase (human Recombinant)
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2005-12-02
• Marketing Category: BLA / NDA
• Application Number: BLA021859
• Labeler Name: A-S Medication Solutions
• Substance Name: HYALURONIDASE (HUMAN RECOMBINANT)
• Active Ingredient Strength: 150 [USP'U]/mL
• Pharm Classes: Endoglycosidase [EPC],Glycoside Hydrolases [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 50090-4534-0

1 mL in 1 VIAL (50090-4534-0)

• Marketing Start Date: 2019-09-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50090-4534-0 [50090453400]

HYLENEX Recombinant INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA021859
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-09-18

Drug Details

Active Ingredients

Ingredient	Strength
HYALURONIDASE (HUMAN RECOMBINANT)	150 [USP'U]/mL

OpenFDA Data

• SPL SET ID: 75f75f29-e369-449d-aa46-179ae02d1fe9
• Manufacturer:
  • A-S Medication Solutions
• UNII:
  • 743QUY4VD8
• RxNorm Concept Unique ID - RxCUI:
  • 630936
  • 630939

Pharmacological Class

• Endoglycosidase [EPC]
• Glycoside Hydrolases [CS]
• Endoglycosidase [EPC]
• Glycoside Hydrolases [CS]

NDC Crossover Matching brand name "HYLENEX Recombinant" or generic name "Hyaluronidase (human Recombinant)"

NDC	Brand Name	Generic Name
18657-117	HYLENEX Recombinant	Hyaluronidase (Human Recombinant)
50090-4534	HYLENEX Recombinant	Hyaluronidase (Human Recombinant)