CARBAMAZEPINE

Product NDC

0615-4515

11-digit product format

006154515

Labeler code

0615

Product ID

0615-4515_05a19461-16b8-443f-ab47-ff5c96e3694a

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

CARBAMAZEPINE

Dosage form

TABLET

Route

ORAL

Labeler

NCS HealthCare of KY, Inc dba Vangard Labs

Application

ANDA077272

Marketing category

ANDA

Marketing start

2005-12-07

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

E

Listing certified through

2017-12-31

Current FDA listing

Historical FDA.report record