Tegretol

Product NDC

70518-0337

11-digit product format

705180337

Labeler code

70518

Product ID

70518-0337_a43ebc9c-06c3-50d3-e053-2995a90ad9ed

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

carbamazepine

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Labeler

REMEDYREPACK INC.

Application

NDA020234

Marketing category

NDA

Marketing start

2017-03-20

Marketing end

0000-00-00

Substance

CARBAMAZEPINE

Active strength

100 mg/1

Pharmacologic classes

Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA]

NDC exclude flag

No

Listing certified through

2021-12-31

Current FDA listing

Historical FDA.report record