CARBAMAZEPINE

Product NDC

49999-616

11-digit product format

499990616

Labeler code

49999

Product ID

49999-616_01f75cae-b8fe-4563-ae31-1bb31a3e804a

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

CARBAMAZEPINE

Dosage form

TABLET

Route

ORAL

Labeler

Lake Erie Medical DBA Quality Care Products LLC

Application

ANDA077272

Marketing category

ANDA

Marketing start

2009-10-23

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

2019-12-31

Current FDA listing

Historical FDA.report record