Carbamazepine

Product NDC
71335-3002
11-digit product format
713353002
Labeler code
71335
Product ID
71335-3002_cc3be56a-d04e-4886-a6af-3ad6046a7fe0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbamazepine
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078986
Marketing category
ANDA
Marketing start
2012-03-23
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 formatDescriptionMarketing startSampleExclude flagStatus
71335-3002-171335300201120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-3002-1) 2025-11-05NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Carbamazepine Extended-Release Capsules 100 mg, 200 mg and 300 mg Rx onlyBryant Ranch Prepack2025-11-05HUMAN PRESCRIPTION DRUG LABEL100