Carbamazepine

Product NDC
72162-1715
11-digit product format
721621715
Labeler code
72162
Product ID
72162-1715_34f755de-a8e8-df2d-e063-6294a90acaae
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
300 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
72162-1715-272162171502120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72162-1715-2) 2025-05-12NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Carbamazepine Extended-Release Capsules 100 mg, 200 mg and 300 mg Rx onlyBryant Ranch Prepack2025-05-12HUMAN PRESCRIPTION DRUG LABEL100