Carbamazepine

Product NDC
68084-561
11-digit product format
680840561
Labeler code
68084
Product ID
68084-561_d5410c8d-bcc4-ee14-e053-2995a90a8c3a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbamazepine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
American Health Packaging
Application
NDA020234
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2012-01-05
Marketing end
2023-06-30
Substance
CARBAMAZEPINE
Active strength
200 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-561-11EA - Each68084-5611abcb6f7-2fb1-4492-b936-0805686a58af12012-07-24
68084-561-21EA - Each68084-561d3e47bb5-5b91-44a4-b271-c20fa1cd762a12012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-561-216808405612130 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-561-21) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68084-561-11) 30 blister pack2012-01-050000-00-00NoNoCurrent