Carbamazepine

Product NDC
51079-385
11-digit product format
510790385
Labeler code
51079
Product ID
51079-385_b7006dd3-787e-3ed2-e053-2995a90a491d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbamazepine
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA070541
Marketing category
ANDA
Marketing start
1995-09-28
Marketing end
2021-02-28
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
51079-385-01EA - Each51079-385324b7f23-4781-4a0c-8f12-f744d2b9f9e112012-07-24
51079-385-17EA - Each51079-385012b6c83-4d09-4f8e-a063-164d0bd1be9812012-07-24
51079-385-19EA - Each51079-385b3ccb2bf-f176-423c-b5b6-96940bd1f8de12012-07-24
51079-385-20EA - Each51079-3851bd5b68c-f2b9-40a9-83cc-0b9b4c16746d12012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51079-385-2051079038520100 BLISTER PACK in 1 CARTON (51079-385-20) > 1 TABLET in 1 BLISTER PACK (51079-385-01) 100 blister pack1995-09-282021-02-28NoNoCurrent