Carbamazepine

Product NDC
68094-007
11-digit product format
680940007
Labeler code
68094
Product ID
68094-007_5bac0629-759a-41c1-a760-96a6c2574c51
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbamazepine
Dosage form
SUSPENSION
Route
ORAL
Labeler
Precision Dose, Inc.
Application
ANDA075714
Marketing category
ANDA
Marketing start
2017-10-04
Marketing end
2023-08-31
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
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
68094-007-59ML - Milliliter68094-007349ae93b-21f1-42bc-9b63-18a4cf5c8e5812017-11-06
68094-007-62ML - Milliliter68094-007de723407-5917-4152-a232-81455c18bbeb12017-11-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68094-007-62680940007623 TRAY in 1 CASE (68094-007-62) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (68094-007-59) 3 tray2017-10-042023-08-31NoNoCurrent