LEVETIRACETAM
These highlights do not include all the information needed to use LEVETIRACETAM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM EXTENDED-RELEASE TABLETS. LEVETIRACETAM extended-release tablets, for oral useInitial U.S. Approval: 1999
Approved
Approval ID
5d3ce612-94de-4ad3-b873-27cb09304d45
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 23, 2020
Manufacturers
FDA
Changzhou Pharmaceutical Factory
DUNS: 653881060
Products 1
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 Code55488-0519
Application NumberANDA212688
Product Classification
M
Marketing Category
C73584
G
Generic Name
LEVETIRACETAM
Product Specifications
Route of AdministrationORAL
Effective DateJune 23, 2020
FDA Product Classification
INGREDIENTS (7)
LEVETIRACETAMActive
Quantity: 750 mg in 1 1
Code: 44YRR34555
Classification: ACTIB
HYPROMELLOSE 2208 (100000 MPA.S)Inactive
Code: VM7F0B23ZI
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT