Levetiracetam in Sodium Chloride
These highlights do not include all the information needed to use LEVETIRACETAM IN SODIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for LEVETIRACETAM IN SODIUM CHLORIDE INJECTION.LEVETIRACETAM IN SODIUM CHLORIDE injection, for intravenous useInitial U.S. Approval: 1999
Approved
Approval ID
ee014183-a857-457b-9573-0cc168e560f3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 8, 2023
Manufacturers
FDA
Nexus Pharamaceuticals Inc.
DUNS: 620714787
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Levetiracetam
PRODUCT DETAILS
NDC Product Code14789-220
Application NumberANDA213532
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateJune 8, 2023
Generic NameLevetiracetam
INGREDIENTS (5)
LevetiracetamActive
Quantity: 10 mg in 1 mL
Code: 44YRR34555
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATER O-18Inactive
Code: 7QV8F8BYNJ
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
Levetiracetam
PRODUCT DETAILS
NDC Product Code14789-110
Application NumberANDA213532
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateJune 8, 2023
Generic NameLevetiracetam
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
LevetiracetamActive
Quantity: 5 mg in 1 mL
Code: 44YRR34555
Classification: ACTIB
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
WATER O-18Inactive
Code: 7QV8F8BYNJ
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
Levetiracetam
PRODUCT DETAILS
NDC Product Code14789-330
Application NumberANDA213532
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateJune 8, 2023
Generic NameLevetiracetam
INGREDIENTS (5)
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
LevetiracetamActive
Quantity: 15 mg in 1 mL
Code: 44YRR34555
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATER O-18Inactive
Code: 7QV8F8BYNJ
Classification: IACT