Levetiracetam

Basic Information

Product Name

Levetiracetam

FDA Product Code

31722-537

Regulatory Information

NDC Product Code

31722-537

Application Number

ANDA090515

Marketing Category

C73584

Effective Date

April 2, 2024

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

TALC

Code: 7SEV7J4R1U

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

POVIDONE

Code: FZ989GH94E

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

POLYVINYL ALCOHOL, UNSPECIFIED

Code: 532B59J990

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

POLYETHYLENE GLYCOL 3350

Code: G2M7P15E5P

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

LEVETIRACETAM

Quantity: 500 mg in 1 1

Code: 44YRR34555

Class Code: ACTIB

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

Active Moieties

Code: 44YRR34555

Levetiracetam

Basic Information

Regulatory Information

Company Information

Active Ingredients

TALC

STARCH, CORN

CROSCARMELLOSE SODIUM

POVIDONE

TITANIUM DIOXIDE

POLYVINYL ALCOHOL, UNSPECIFIED

FERRIC OXIDE YELLOW

POLYETHYLENE GLYCOL 3350

SILICON DIOXIDE

MAGNESIUM STEARATE

Active Moieties

LEVETIRACETAM