Carbamazepine

Product NDC
63629-9292
11-digit product format
636299292
Labeler code
63629
Product ID
63629-9292_9b8459bd-bba3-4308-9360-161989d72674
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbamazepine
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA073524
Marketing category
ANDA
Marketing start
1995-09-18
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-9292-1EA - Each63629-929253eb4672-a034-425e-9cc1-782dcf3135ee12022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9292CARBAMAZEPINE TABLET, CHEWABLE [BRYANT RANCH PREPACK]102Legacy NDC20240602_3469d22a-338f-44d5-b515-0fb4ed675e5b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-9292-163629929201100 TABLET, CHEWABLE in 1 BOTTLE (63629-9292-1) 2022-06-060000-00-00NoNoCurrent