Oxcarbazepine

Basic Information

Product Name

Oxcarbazepine

FDA Product Code

54868-6073

Regulatory Information

NDC Product Code

54868-6073

Application Number

ANDA077802

Marketing Category

C73584

Effective Date

December 14, 2011

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use Oxcarbazepine Tablets safely and effectively. See full prescribing information for Oxcarbazepine Tablets. Oxcarbazepine Tablets Initial U.S. Approval: 2000

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

OXCARBAZEPINE

Quantity: 300 mg in 1 1

Code: VZI5B1W380

Class Code: ACTIB

CROSPOVIDONE

Code: 68401960MK

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

MEGLUMINE

Code: 6HG8UB2MUY

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

POLYETHYLENE GLYCOL

Code: 3WJQ0SDW1A

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

Active Moieties

Code: VZI5B1W380

Oxcarbazepine

Basic Information

Regulatory Information

Company Information

Active Ingredients

CROSPOVIDONE

SILICON DIOXIDE

MAGNESIUM STEARATE

FERRIC OXIDE YELLOW

HYPROMELLOSES

MEGLUMINE

CELLULOSE, MICROCRYSTALLINE

POLYETHYLENE GLYCOL

TITANIUM DIOXIDE

Active Moieties

OXCARBAZEPINE