Carbamazepine

Product NDC
0121-0947
11-digit product format
001210947
Labeler code
0121
Product ID
0121-0947_cff80ddc-2a16-7b93-e053-2995a90aed9e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbamazepine
Dosage form
SUSPENSION
Route
ORAL
Labeler
Pharamaceutical Associates, Inc.
Application
ANDA076729
Marketing category
ANDA
Marketing start
2021-10-07
Marketing end
0000-00-00
Substance
CARBAMAZEPINE
Active strength
100 mg/5mL
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0947-05ML - Milliliter0121-09473e7e434c-0061-4337-950d-cfdc14af2b2812022-01-06
0121-0947-94ML - Milliliter0121-0947cc6893d9-85ed-4026-ab0d-000383d91da512022-01-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-0947-94001210947943 TRAY in 1 CASE (0121-0947-94) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE (0121-0947-05) 3 tray2021-10-070000-00-00NoNoCurrent