Tegretol

Product NDC

70518-1452

11-digit product format

705181452

Labeler code

70518

Product ID

70518-1452_92def18b-e14c-3823-e053-2995a90ac447

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

carbamazepine

Dosage form

TABLET

Route

ORAL

Labeler

REMEDYREPACK INC.

Application

NDA016608

Marketing category

NDA

Marketing start

2018-10-02

Marketing end

0000-00-00

Substance

CARBAMAZEPINE

Active strength

200 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

2020-12-31

Current FDA listing

Historical FDA.report record