Lamotrigine

Product NDC
70518-3187
11-digit product format
705183187
Labeler code
70518
Product ID
70518-3187_c93afead-3841-e47f-e053-2a95a90a6743
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA207497
Marketing category
ANDA
Marketing start
2021-08-10
Marketing end
0000-00-00
Substance
LAMOTRIGINE
Active strength
50 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
70518-3187-02023-03-20C16284748780-1f386c64a-1c6a-0266-e053-dadaa90a7c1a24168367-76f3-40cf-b1cc-93664e2a8eb9
70518-3187-02023-01-30C16284748780-1f386c64a-1c6a-0266-e053-dadaa90a7c1a24168367-76f3-40cf-b1cc-93664e2a8eb9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3187-07051831870030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (70518-3187-0) 2021-08-100000-00-00NoNoCurrent