NDC 0548-9090

AMPHADASE

Hyaluronidase

AMPHADASE is a Subcutaneous Injection in the Human Prescription Drug category. It is labeled and distributed by Amphastar Pharmaceuticals, Inc.. The primary component is Hyaluronidase.

• Product ID: 0548-9090_9d798dca-17f4-4ab4-9c1e-7d6f4f1bfa40
• NDC: 0548-9090
• Product Type: Human Prescription Drug
• Proprietary Name: AMPHADASE
• Generic Name: Hyaluronidase
• Dosage Form: Injection
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2004-10-26
• Marketing Category: NDA / NDA
• Application Number: NDA021665
• Labeler Name: Amphastar Pharmaceuticals, Inc.
• Substance Name: HYALURONIDASE
• Active Ingredient Strength: 150 [USP'U]/mL
• Pharm Classes: Endoglycosidase [EPC],Glycoside Hydrolases [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0548-9090-10

10 VIAL, SINGLE-DOSE in 1 CARTON (0548-9090-10) > 1 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2004-10-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0548-9090-10 [00548909010]

AMPHADASE INJECTION

• Marketing Category: NDA
• Application Number: NDA021665
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2004-10-26

NDC 0548-9090-00 [00548909000]

AMPHADASE INJECTION

• Marketing Category: NDA
• Application Number: NDA021665
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2004-10-26
• Marketing End Date: 2014-05-16

Drug Details

Active Ingredients

Ingredient	Strength
HYALURONIDASE	150 [USP'U]/mL

OpenFDA Data

• SPL SET ID: 8396ea96-7cb5-4e26-87a4-90bca9c3c6dd
• Manufacturer:
  • Amphastar Pharmaceuticals, Inc.
• UNII:
  • 8KOG53Z5EM
• RxNorm Concept Unique ID - RxCUI:
  • 238271
  • 542925

Pharmacological Class

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

NDC Crossover Matching brand name "AMPHADASE" or generic name "Hyaluronidase"

NDC	Brand Name	Generic Name
0548-9090	AMPHADASE	hyaluronidase
51662-1555	HYALURONIDASE	HYALURONIDASE
17478-560	Hydase	Hyaluronidase