CARBAMAZEPINE

Product NDC
63629-8715
11-digit product format
636298715
Labeler code
63629
Product ID
63629-8715_fd4d9815-6235-4602-b574-0b10e745555a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARBAMAZEPINE
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075948
Marketing category
ANDA
Marketing start
2002-09-01
Marketing end
0000-00-00
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
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
63629-8715-1EA - Each63629-871595795c63-b999-4269-ac0d-6e0311a6a02712021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8715CARBAMAZEPINE TABLET [BRYANT RANCH PREPACK]106Legacy NDC20240823_9f0a6cd8-7274-4983-a4fc-c6617f2b3c8a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8715-163629871501100 TABLET in 1 BOTTLE (63629-8715-1) 100 tablet2021-08-190000-00-00NoNoCurrent