Levetiracetam
These highlights do not include all the information needed to use LEVETIRACETAM TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS. LEVETIRACETAM tablets, for oral use Initial U.S. Approval: 1999
Approved
Approval ID
fc8bf57e-8aa2-4d3c-856d-b19de65e3ba0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 8, 2023
Manufacturers
FDA
American Health Packaging
DUNS: 929561009
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Levetiracetam
PRODUCT DETAILS
NDC Product Code68084-893
Application NumberANDA078993
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 8, 2023
Generic NameLevetiracetam
INGREDIENTS (10)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
LEVETIRACETAMActive
Quantity: 1000 mg in 1 1
Code: 44YRR34555
Classification: ACTIB
Levetiracetam
PRODUCT DETAILS
NDC Product Code68084-859
Application NumberANDA078993
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 8, 2023
Generic NameLevetiracetam
INGREDIENTS (12)
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
LEVETIRACETAMActive
Quantity: 250 mg in 1 1
Code: 44YRR34555
Classification: ACTIB
Levetiracetam
PRODUCT DETAILS
NDC Product Code68084-882
Application NumberANDA078993
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 8, 2023
Generic NameLevetiracetam
INGREDIENTS (14)
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
LEVETIRACETAMActive
Quantity: 750 mg in 1 1
Code: 44YRR34555
Classification: ACTIB
Levetiracetam
PRODUCT DETAILS
NDC Product Code68084-870
Application NumberANDA078993
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 8, 2023
Generic NameLevetiracetam
INGREDIENTS (12)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
LEVETIRACETAMActive
Quantity: 500 mg in 1 1
Code: 44YRR34555
Classification: ACTIB