Carbamazepine

Product NDC
50090-4443
11-digit product format
500904443
Labeler code
50090
Product ID
50090-4443_1581cb47-5b74-4ebc-8423-be78817fb97d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbamazepine
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA074649
Marketing category
ANDA
Marketing start
1996-10-03
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
2022-12-31
Current FDA listing
Historical FDA.report record

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
33CM23913MCARBAMAZEPINE298-46-4CARBAMAZEPINE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4443-05009044430032 BLISTER PACK in 1 BOX, UNIT-DOSE (50090-4443-0) > 1 TABLET in 1 BLISTER PACK32 blister pack2019-08-010000-00-00NoNoCurrent