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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4443-02023-02-07C16284748780-1f386c649-f325-0266-e053-dadaa90a7c1a8ed1d4d7-ff8a-474c-856e-ed19418faaa0
50090-4443-02023-01-30C16284748780-1f386c649-f325-0266-e053-dadaa90a7c1a8ed1d4d7-ff8a-474c-856e-ed19418faaa0

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4443-0EA - Each50090-44430f35da6a-77f0-4830-a340-d2447980e2c812022-07-06

Packages#

Package NDC, 11-digit format, Description table
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