MedPath
FDA Product

Levetiracetam

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Levetiracetam

71335-0748

Regulatory Information

71335-0748

ANDA078106

C73584

September 24, 2019

USA

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

HUMAN PRESCRIPTION DRUG LABEL

4

Company Information

171714327

Active Ingredients

LEVETIRACETAM

Quantity: 500 mg in 1 1

Code: 44YRR34555

Class Code: ACTIB

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

FD&C BLUE NO. 2

Code: L06K8R7DQK

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

D&C RED NO. 27

Code: 2LRS185U6K

Class Code: IACT

HYPROMELLOSE 2910 (3 MPA.S)

Code: 0VUT3PMY82

Class Code: IACT

HYPROMELLOSE 2910 (6 MPA.S)

Code: 0WZ8WG20P6

Class Code: IACT

POLYDEXTROSE

Code: VH2XOU12IE

Class Code: IACT

HYPROMELLOSE 2910 (50 MPA.S)

Code: 1IVH67816N

Class Code: IACT

POLYETHYLENE GLYCOL 800

Code: UH6KR4953D

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

FD&C RED NO. 40

Code: WZB9127XOA

Class Code: IACT

FD&C YELLOW NO. 6

Code: H77VEI93A8

Class Code: IACT

POVIDONE, UNSPECIFIED

Code: FZ989GH94E

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

TRIACETIN

Code: XHX3C3X673

Class Code: IACT

Active Moieties

LEVETIRACETAM

Code: 44YRR34555

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