Levetiracetam
These highlights do not include all the information needed to use levetiracetamsafely and effectively. See full prescribing information for levetiracetam.
Approved
Approval ID
ee03507b-cb35-4fe9-ae7b-85ea89f876f0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 5, 2018
Manufacturers
FDA
Dr. Reddy's Laboratories Limited
DUNS: 650562841
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 Code55111-181
Application NumberANDA076920
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 5, 2018
Generic NameLevetiracetam
INGREDIENTS (15)
levetiracetamActive
Quantity: 250 mg in 1 1
Code: 44YRR34555
Classification: ACTIB
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
povidoneInactive
Code: FZ989GH94E
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
hypromellose 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
sodium starch glycolate type A potatoInactive
Code: 5856J3G2A2
Classification: IACT
hypromellose 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
ferric oxide redInactive
Code: 1K09F3G675
Classification: IACT
ferric oxide yellowInactive
Code: EX438O2MRT
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
polyethylene glycol 400Inactive
Code: B697894SGQ
Classification: IACT
Levetiracetam
PRODUCT DETAILS
NDC Product Code55111-182
Application NumberANDA076920
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 5, 2018
Generic NameLevetiracetam
INGREDIENTS (15)
levetiracetamActive
Quantity: 500 mg in 1 1
Code: 44YRR34555
Classification: ACTIB
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
povidoneInactive
Code: FZ989GH94E
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
sodium starch glycolate type A potatoInactive
Code: 5856J3G2A2
Classification: IACT
ferric oxide yellowInactive
Code: EX438O2MRT
Classification: IACT
ferric oxide redInactive
Code: 1K09F3G675
Classification: IACT
polyethylene glycol 400Inactive
Code: B697894SGQ
Classification: IACT
hypromellose 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
hypromellose 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
Levetiracetam
PRODUCT DETAILS
NDC Product Code55111-183
Application NumberANDA076920
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 5, 2018
Generic NameLevetiracetam
INGREDIENTS (15)
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
levetiracetamActive
Quantity: 750 mg in 1 1
Code: 44YRR34555
Classification: ACTIB
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
povidoneInactive
Code: FZ989GH94E
Classification: IACT
hypromellose 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
sodium starch glycolate type A potatoInactive
Code: 5856J3G2A2
Classification: IACT
hypromellose 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
ferric oxide redInactive
Code: 1K09F3G675
Classification: IACT
ferric oxide yellowInactive
Code: EX438O2MRT
Classification: IACT
polyethylene glycol 400Inactive
Code: B697894SGQ
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT