Lamotrigine

Product NDC
70518-3043
11-digit product format
705183043
Labeler code
70518
Product ID
70518-3043_bd336112-cff5-8b0d-e053-2995a90a89d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078956
Marketing category
ANDA
Marketing start
2021-03-10
Marketing end
0000-00-00
Substance
LAMOTRIGINE
Active strength
25 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-3043-02023-03-15C16284748780-1f386c64a-066f-0266-e053-dadaa90a7c1a6ef17301-6c0b-4941-a84d-12243875d2e2
70518-3043-02023-01-30C16284748780-1f386c64a-066f-0266-e053-dadaa90a7c1a6ef17301-6c0b-4941-a84d-12243875d2e2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3043LAMOTRIGINE TABLET [REMEDYREPACK INC.]7Legacy NDC20250418_6ef17301-6c0b-4941-a84d-12243875d2e2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3043-070518304300180 TABLET in 1 BOTTLE, PLASTIC (70518-3043-0) 180 tablet2021-03-100000-00-00NoNoCurrent