CARBAMAZEPINE

Product NDC
70518-2456
11-digit product format
705182456
Labeler code
70518
Product ID
70518-2456_dbe937e7-dd8b-52c0-e053-2995a90a09d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARBAMAZEPINE
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077272
Marketing category
ANDA
Marketing start
2019-11-26
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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2456CARBAMAZEPINE TABLET [REMEDYREPACK INC.]9Legacy NDC20250316_b0ba2cd6-c18f-4559-a5ea-50aa9039585c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2456-07051824560030 TABLET in 1 BLISTER PACK (70518-2456-0) 30 tablet2019-11-260000-00-00NoNoCurrent