CARBAMAZEPINE

Product NDC
70518-3335
11-digit product format
705183335
Labeler code
70518
Product ID
70518-3335_d5f12c5f-903e-ec9b-e053-2995a90a60b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARBAMAZEPINE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA211623
Marketing category
ANDA
Marketing start
2022-01-18
Marketing end
0000-00-00
Substance
CARBAMAZEPINE
Active strength
200 mg/1
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3335-070518333500100 POUCH in 1 BOX (70518-3335-0) > 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-3335-1) 100 pouch2022-01-180000-00-00NoNoCurrent