Lamotrigine

Product NDC
70518-3150
11-digit product format
705183150
Labeler code
70518
Product ID
70518-3150_c71a93fb-e0cc-e592-e053-2995a90a45d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078525
Marketing category
ANDA
Marketing start
2021-07-13
Marketing end
0000-00-00
Substance
LAMOTRIGINE
Active strength
150 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
70518-3150-02023-03-17C16284748780-1f386c649-a5ef-0266-e053-dadaa90a7c1a17c978af-8ede-4005-9712-9a27de872394
70518-3150-02023-01-30C16284748780-1f386c649-a5ef-0266-e053-dadaa90a7c1a17c978af-8ede-4005-9712-9a27de872394

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3150-07051831500030 POUCH in 1 BOX (70518-3150-0) > 1 TABLET in 1 POUCH (70518-3150-1) 30 pouch2021-07-130000-00-00NoNoCurrent