Carbamazepine

Product NDC
70518-1545
11-digit product format
705181545
Labeler code
70518
Product ID
70518-1545_ed218a21-df32-5044-e053-2995a90a37bf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbamazepine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078115
Marketing category
ANDA
Marketing start
2018-10-17
Marketing end
0000-00-00
Substance
CARBAMAZEPINE
Active strength
400 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
70518-1545-07051815450030 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-1545-0) 2018-10-170000-00-00NoNoCurrent
70518-1545-170518154501100 POUCH in 1 BOX (70518-1545-1) > 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-1545-2) 100 pouch2022-11-050000-00-00NoNoCurrent