Carbamazepine

Product NDC
63629-8753
11-digit product format
636298753
Labeler code
63629
Product ID
63629-8753_3b67c5f2-b7be-45f7-964d-4105ec2e4676
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbamazepine
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA070541
Marketing category
ANDA
Marketing start
1990-09-30
Substance
CARBAMAZEPINE
Active strength
200 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
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
33CM23913MCARBAMAZEPINE298-46-4CARBAMAZEPINE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63629-8753-1636298753011000 TABLET in 1 BOTTLE (63629-8753-1) 1000 tablet2021-08-20NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
CARBAMAZEPINE TABLETS, USP 200 mg CARBAMAZEPINE TABLETS, USP (CHEWABLE) 100 mg Rx onlyBryant Ranch Prepack2024-05-30HUMAN PRESCRIPTION DRUG LABEL103