MedPath
FDA Product

Levetiracetam

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

Basic Information

Levetiracetam

68258-7089

Regulatory Information

68258-7089

ANDA078993

C73584

August 20, 2013

USA

These highlights do not include all the information needed to use levetiracetam tablets safely and effectively. See full prescribing information for levetiracetam tablets USP. Levetiracetam Tablets USP for Oral Use Initial U.S. Approval: 1999

Human Prescription Drug Label

1

Company Information

066070785

Active Ingredients

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

LEVETIRACETAM

Quantity: 250 mg in 1 1

Code: 44YRR34555

Class Code: ACTIB

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

POVIDONE K30

Code: U725QWY32X

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

HYPROMELLOSE 2910 (6 MPA.S)

Code: 0WZ8WG20P6

Class Code: IACT

HYPROMELLOSE 2910 (3 MPA.S)

Code: 0VUT3PMY82

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

FD&C BLUE NO. 2

Code: L06K8R7DQK

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

POLYETHYLENE GLYCOL 4000

Code: 4R4HFI6D95

Class Code: IACT

Active Moieties

LEVETIRACETAM

Code: 44YRR34555

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