Carbamazepine

Product NDC
70518-1769
11-digit product format
705181769
Labeler code
70518
Product ID
70518-1769_bd07a50a-9f65-1ca4-e053-2995a90ab182
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbamazepine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078115
Marketing category
ANDA
Marketing start
2019-01-02
Marketing end
0000-00-00
Substance
CARBAMAZEPINE
Active strength
100 mg/1
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

FDA-Initiated Inactive NDC Indexing#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-1769-07051817690030 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-1769-0) 2019-01-020000-00-00NoNoCurrent
70518-1769-170518176901100 POUCH in 1 BOX (70518-1769-1) > 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-1769-2) 100 pouch2019-10-170000-00-00NoNoCurrent