Simulect
Simulect (basiliximab) For Injection Rx only Prescribing Information
Approved
Approval ID
1af01887-b69d-444b-91ed-ebfe12784440
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 1, 2023
Manufacturers
FDA
Novartis Pharmaceuticals Corporation
DUNS: 002147023
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
basiliximab
PRODUCT DETAILS
NDC Product Code0078-0393
Application NumberBLA103764
Marketing CategoryC73585
Route of AdministrationINTRAVENOUS
Effective DateDecember 5, 2019
Generic Namebasiliximab
INGREDIENTS (7)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Quantity: 0.50 mg in 2.5 mL
Code: 22ADO53M6F
Classification: IACT
GLYCINEInactive
Quantity: 20 mg in 2.5 mL
Code: TE7660XO1C
Classification: IACT
MANNITOLInactive
Quantity: 41 mg in 2.5 mL
Code: 3OWL53L36A
Classification: IACT
BASILIXIMABActive
Quantity: 10 mg in 2.5 mL
Code: 9927MT646M
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 0.82 mg in 2.5 mL
Code: 451W47IQ8X
Classification: IACT
POTASSIUM PHOSPHATE, MONOBASICInactive
Quantity: 3.66 mg in 2.5 mL
Code: 4J9FJ0HL51
Classification: IACT
SUCROSEInactive
Quantity: 10 mg in 2.5 mL
Code: C151H8M554
Classification: IACT
basiliximab
PRODUCT DETAILS
NDC Product Code0078-0331
Application NumberBLA103764
Marketing CategoryC73585
Route of AdministrationINTRAVENOUS
Effective DateDecember 5, 2019
Generic Namebasiliximab
INGREDIENTS (7)
MANNITOLInactive
Quantity: 80 mg in 5 mL
Code: 3OWL53L36A
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 1.61 mg in 5 mL
Code: 451W47IQ8X
Classification: IACT
GLYCINEInactive
Quantity: 40 mg in 5 mL
Code: TE7660XO1C
Classification: IACT
SUCROSEInactive
Quantity: 20 mg in 5 mL
Code: C151H8M554
Classification: IACT
BASILIXIMABActive
Quantity: 20 mg in 5 mL
Code: 9927MT646M
Classification: ACTIB
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Quantity: 0.99 mg in 5 mL
Code: 22ADO53M6F
Classification: IACT
POTASSIUM PHOSPHATE, MONOBASICInactive
Quantity: 7.22 mg in 5 mL
Code: 4J9FJ0HL51
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 2/12/2021
PRINCIPAL DISPLAY PANEL
NOVARTIS NDC 0078-0331-84
Simulect®
(basiliximab)
for injection
20 mg (single-dose vial)
FOR INTRAVENOUS ADMINISTRATION AFTER RECONSTITUTION.
Discard unused portion.
Rx only
