Carbamazepine

Product NDC
63629-8721
11-digit product format
636298721
Labeler code
63629
Product ID
63629-8721_2ecc89f5-c281-4223-bacb-121669a802c9
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
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
63629-8721-1EA - Each63629-8721b09710a2-2dd8-4f6e-9e97-5497caccdc9f12021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8721CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]105Legacy NDC20241024_ba5615c0-8f30-431b-add4-41965e3ca04b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8721-163629872101120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-8721-1) 2012-03-230000-00-00NoNoCurrent