Carbamazepine

Product NDC
0121-0862
11-digit product format
001210862
Labeler code
0121
Product ID
0121-0862_6480cf3e-b4a0-4dfc-b505-6c74bcddcdff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbamazepine
Dosage form
SUSPENSION
Route
ORAL
Labeler
PAI Holdings, LLC
Application
ANDA075714
Marketing category
ANDA
Marketing start
2002-06-05
Marketing end
0000-00-00
Substance
CARBAMAZEPINE
Active strength
100 mg/5mL
Pharmacologic classes
Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0862-05ML - Milliliter0121-0862a3d8c898-463f-4e63-81d0-58d3aa5df48112020-07-13
0121-0862-30ML - Milliliter0121-0862b31b7b15-a9cb-46fe-a6ed-f569daedb78812020-07-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-0862-30001210862303 TRAY in 1 CASE (0121-0862-30) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (0121-0862-05) 3 tray2020-05-140000-00-00NoNoCurrent