KEPIVANCE
These highlights do not include all the information needed to use Kepivance safely and effectively. See full prescribing information for KEPIVANCE. KEPIVANCE (palifermin) for injection, for intravenous use Initial U.S. Approval: 2004
Approved
Approval ID
426f6e64-2c20-4a61-6d65-7320426f6e64
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 1, 2023
Manufacturers
FDA
Swedish Orphan Biovitrum AB (publ)
DUNS: 354010589
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
palifermin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66658-113
Application NumberBLA125103
Product Classification
M
Marketing Category
C73585
G
Generic Name
palifermin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 1, 2023
FDA Product Classification
INGREDIENTS (5)
paliferminActive
Quantity: 5.16 mg in 1.2 mL
Code: QMS40680K6
Classification: ACTIB
mannitolInactive
Quantity: 41 mg in 1.2 mL
Code: 3OWL53L36A
Classification: IACT
sucroseInactive
Quantity: 21 mg in 1.2 mL
Code: C151H8M554
Classification: IACT
histidineInactive
Quantity: 1.6 mg in 1.2 mL
Code: 4QD397987E
Classification: IACT
polysorbate 20Inactive
Quantity: 0.11 mg in 1.2 mL
Code: 7T1F30V5YH
Classification: IACT
palifermin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66658-112
Application NumberBLA125103
Product Classification
M
Marketing Category
C73585
G
Generic Name
palifermin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 1, 2023
FDA Product Classification
INGREDIENTS (5)
paliferminActive
Quantity: 6.25 mg in 1.2 mL
Code: QMS40680K6
Classification: ACTIB
mannitolInactive
Quantity: 50 mg in 1.2 mL
Code: 3OWL53L36A
Classification: IACT
histidineInactive
Quantity: 1.94 mg in 1.2 mL
Code: 4QD397987E
Classification: IACT
sucroseInactive
Quantity: 25 mg in 1.2 mL
Code: C151H8M554
Classification: IACT
polysorbate 20Inactive
Quantity: 0.13 mg in 1.2 mL
Code: 7T1F30V5YH
Classification: IACT