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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55111-181
Application NumberANDA076920
Product Classification
M
Marketing Category
C73584
G
Generic Name
Levetiracetam
Product Specifications
Route of AdministrationORAL
Effective DateDecember 5, 2018
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55111-182
Application NumberANDA076920
Product Classification
M
Marketing Category
C73584
G
Generic Name
Levetiracetam
Product Specifications
Route of AdministrationORAL
Effective DateDecember 5, 2018
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55111-183
Application NumberANDA076920
Product Classification
M
Marketing Category
C73584
G
Generic Name
Levetiracetam
Product Specifications
Route of AdministrationORAL
Effective DateDecember 5, 2018
FDA Product Classification
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