Carbamazepine

Product NDC
0615-3505
11-digit product format
006153505
Labeler code
0615
Product ID
0615-3505_4b5b9199-1ceb-40de-b0c2-321bc299e601
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbamazepine
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, Inc dba Vangard Labs
Application
ANDA070541
Marketing category
ANDA
Marketing start
1990-09-30
Marketing end
0000-00-00
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
2020-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-3505-390061535053930 TABLET in 1 BLISTER PACK (0615-3505-39) 30 tablet1990-09-300000-00-00NoNoCurrent