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
5e5b0ed3-b104-45a7-bb3e-ee56febb46e8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 30, 2023
Manufacturers
FDA
WG Critical Care, LLC
DUNS: 829274633
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Levetiracetam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code44567-501
Application NumberNDA202543
Product Classification
M
Marketing Category
C73594
G
Generic Name
Levetiracetam
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 30, 2023
FDA Product Classification
INGREDIENTS (6)
LEVETIRACETAMActive
Quantity: 5 mg in 1 mL
Code: 44YRR34555
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
NATURAL LATEX RUBBERInactive
Quantity: 0 1 in 1 mL
Code: 2LQ0UUW8IN
Classification: CNTM
Levetiracetam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code44567-502
Application NumberNDA202543
Product Classification
M
Marketing Category
C73594
G
Generic Name
Levetiracetam
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 30, 2023
FDA Product Classification
INGREDIENTS (6)
LEVETIRACETAMActive
Quantity: 10 mg in 1 mL
Code: 44YRR34555
Classification: ACTIB
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
NATURAL LATEX RUBBERInactive
Quantity: 0 1 in 1 mL
Code: 2LQ0UUW8IN
Classification: CNTM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT