Carbamazepine

Product NDC
68094-008
11-digit product format
680940008
Labeler code
68094
Product ID
68094-008_5d9cfaa3-9d66-42fb-86f2-f0f5da1e2bb7
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
2023-06-30
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
68094-008-59ML - Milliliter68094-008f391841c-01c1-42ba-8e45-6cf3ea27b5a712017-11-06
68094-008-62ML - Milliliter68094-008acdac9c6-e1fa-48bb-a641-575fad188ccc12017-11-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68094-008-62680940008623 TRAY in 1 CASE (68094-008-62) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE (68094-008-59) 3 tray2017-10-042023-06-30NoNoCurrent