CARBAMAZEPINE

Product NDC
70518-2489
11-digit product format
705182489
Labeler code
70518
Product ID
70518-2489_dbfe86e8-c075-2a84-e053-2a95a90a1f3d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARBAMAZEPINE
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077272
Marketing category
ANDA
Marketing start
2019-12-17
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-2489-4EA - Each70518-248903515588-5f89-4472-a2de-3f8da78589b212026-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2489CARBAMAZEPINE TABLET [REMEDYREPACK INC.]11Legacy NDC20250316_d5f53fa2-d787-4c76-b9f4-4b823c8743f9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2489-070518248900100 POUCH in 1 BOX (70518-2489-0) > 1 TABLET in 1 POUCH (70518-2489-1) 100 pouch2019-12-170000-00-00NoNoCurrent
70518-2489-270518248902100 POUCH in 1 BOX (70518-2489-2) > 1 TABLET in 1 POUCH (70518-2489-3) 100 pouch2020-09-280000-00-00NoNoCurrent
70518-2489-47051824890430 TABLET in 1 BLISTER PACK (70518-2489-4) 30 tablet2020-12-100000-00-00NoNoCurrent
70518-2489-570518248905100 POUCH in 1 BOX (70518-2489-5) > 1 TABLET in 1 POUCH (70518-2489-6) 100 pouch2021-08-060000-00-00NoNoCurrent