AMPHADASE
These highlights do not include all the information needed to use AMPHADASE safely and effectively. See full prescribing information for AMPHADASE.Amphadase (hyaluronidase injection)Initial U.S. Approval: 2005
Approved
Approval ID
8396ea96-7cb5-4e26-87a4-90bca9c3c6dd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 28, 2020
Manufacturers
FDA
Amphastar Pharmaceuticals, Inc.
DUNS: 024736733
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
hyaluronidase
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0548-9090
Application NumberBLA021665
Product Classification
M
Marketing Category
C73585
G
Generic Name
hyaluronidase
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateMay 28, 2020
FDA Product Classification
INGREDIENTS (6)
sodium chlorideInactive
Quantity: 8.5 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
hyaluronidaseActive
Quantity: 150 [USP'U] in 1 mL
Code: 8KOG53Z5EM
Classification: ACTIB
SODIUM PHOSPHATE, MONOBASICInactive
Code: 3980JIH2SW
Classification: IACT
edetate disodiumInactive
Quantity: 1 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT
calcium chlorideInactive
Quantity: 0.4 mg in 1 mL
Code: M4I0D6VV5M
Classification: IACT
thimerosalInactive
Code: 2225PI3MOV
Classification: IACT