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
NDC Product Code0548-9090
Application NumberBLA021665
Marketing CategoryC73585
Route of AdministrationSUBCUTANEOUS
Effective DateMay 28, 2020
Generic Namehyaluronidase
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