CARBAMAZEPINE

Product NDC
63629-8255
11-digit product format
636298255
Labeler code
63629
Product ID
63629-8255_6d1c425d-6ecb-44c5-aba8-171940e07a19
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARBAMAZEPINE
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075712
Marketing category
ANDA
Marketing start
2009-08-26
Marketing end
0000-00-00
Substance
CARBAMAZEPINE
Active strength
100 mg/1
Pharmacologic classes
Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8255-16362982550130 TABLET, CHEWABLE in 1 BOTTLE (63629-8255-1) 2009-08-260000-00-00NoNoCurrent
63629-8255-26362982550260 TABLET, CHEWABLE in 1 BOTTLE (63629-8255-2) 2009-08-260000-00-00NoNoCurrent
63629-8255-363629825503180 TABLET, CHEWABLE in 1 BOTTLE (63629-8255-3) 2009-08-260000-00-00NoNoCurrent