Carbamazepine

Product NDC

51079-870

11-digit product format

510790870

Labeler code

51079

Product ID

51079-870_946dc9f0-39d1-8b21-e053-2995a90a0501

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Carbamazepine

Dosage form

TABLET, CHEWABLE

Route

ORAL

Labeler

Mylan Institutional Inc.

Application

ANDA073524

Marketing category

ANDA

Marketing start

1996-05-15

Marketing end

2020-04-30

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

0000-00-00

Current FDA listing

Historical FDA.report record