Carbamazepine

Product NDC
0121-1724
11-digit product format
001211724
Labeler code
0121
Product ID
0121-1724_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
200 mg/10mL
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
0121-1724-10ML - Milliliter0121-1724f9224e2f-a0c7-487a-973a-13f48d4cb81012020-07-13
0121-1724-30ML - Milliliter0121-1724ddc92507-a843-465e-b0cf-8285ed297baf12020-07-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-1724-30001211724303 TRAY in 1 CASE (0121-1724-30) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE (0121-1724-10) 3 tray2020-05-140000-00-00NoNoCurrent