Carbamazepine

Product NDC
66993-408
11-digit product format
669930408
Labeler code
66993
Product ID
66993-408_711ea8fa-f21f-442f-9e10-2b0aa78ae8cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carbamazepine
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Prasco Laboratories
Application
NDA020712
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2011-12-15
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
66993-408-32EA - Each66993-408819693c2-1b8d-48e8-913d-f998b85cd2d912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARBAMAZEPINEACTIVE INGREDIENT33CM23913MCARBAMAZEPINE CAPSULE, EXTENDED RELEASE [PRASCO LABORATORIES]4
CARBAMAZEPINEACTIVE MOIETY33CM23913MCARBAMAZEPINE CAPSULE, EXTENDED RELEASE [PRASCO LABORATORIES]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66993-408CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [PRASCO LABORATORIES]14Legacy NDC20230609_7a1e523a-b377-43dc-b231-7591c4c888ea.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
66993-408-3266993040832120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (66993-408-32) 2011-12-150000-00-00NoNoCurrent