Levetiracetam
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 use Initial U.S. Approval: 1999
Approved
Approval ID
70e52e89-3844-4cd9-a406-b29e9520a12c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 15, 2023
Manufacturers
FDA
Mylan Institutional LLC
DUNS: 790384502
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 Code67457-266
Application NumberNDA202543
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS
Effective DateOctober 15, 2023
Generic NameLevetiracetam
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
LEVETIRACETAMActive
Quantity: 15 mg in 1 mL
Code: 44YRR34555
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
Levetiracetam
PRODUCT DETAILS
NDC Product Code67457-255
Application NumberNDA202543
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS
Effective DateOctober 15, 2023
Generic NameLevetiracetam
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
LEVETIRACETAMActive
Quantity: 5 mg in 1 mL
Code: 44YRR34555
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
Levetiracetam
PRODUCT DETAILS
NDC Product Code67457-265
Application NumberNDA202543
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS
Effective DateOctober 15, 2023
Generic NameLevetiracetam
INGREDIENTS (5)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
LEVETIRACETAMActive
Quantity: 10 mg in 1 mL
Code: 44YRR34555
Classification: ACTIB
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT