Levetiracetam

Basic Information

Product Name

Levetiracetam

FDA Product Code

68084-882

Regulatory Information

NDC Product Code

68084-882

Application Number

ANDA078993

Marketing Category

C73584

Effective Date

December 8, 2023

Territorial Authority

USA

FDA Title

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

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

POVIDONE K30

Code: U725QWY32X

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

HYPROMELLOSE 2910 (3 MPA.S)

Code: 0VUT3PMY82

Class Code: IACT

HYPROMELLOSE 2910 (6 MPA.S)

Code: 0WZ8WG20P6

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

POLYETHYLENE GLYCOL 4000

Code: 4R4HFI6D95

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

FD&C YELLOW NO. 6

Code: H77VEI93A8

Class Code: IACT

FD&C BLUE NO. 2

Code: L06K8R7DQK

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

LEVETIRACETAM

Quantity: 750 mg in 1 1

Code: 44YRR34555

Class Code: ACTIB

Active Moieties

Code: 44YRR34555

Levetiracetam

Basic Information

Regulatory Information

Company Information

Active Ingredients

POVIDONE K30

SILICON DIOXIDE

TALC

STARCH, CORN

MAGNESIUM STEARATE

HYPROMELLOSE 2910 (3 MPA.S)

HYPROMELLOSE 2910 (6 MPA.S)

TITANIUM DIOXIDE

POLYETHYLENE GLYCOL 4000

WATER

FD&C YELLOW NO. 6

FD&C BLUE NO. 2

FERRIC OXIDE RED

Active Moieties

LEVETIRACETAM