Lamotrigine

Product NDC
70518-3139
11-digit product format
705183139
Labeler code
70518
Product ID
70518-3139_c6668bb8-85a2-dec2-e053-2a95a90a0de7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078956
Marketing category
ANDA
Marketing start
2021-07-02
Marketing end
0000-00-00
Substance
LAMOTRIGINE
Active strength
100 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
70518-3139-02023-03-17C16284748780-1f386c64a-226e-0266-e053-dadaa90a7c1a72ce6aea-6cfc-4a6b-8d5d-1466adf5745e
70518-3139-02023-01-30C16284748780-1f386c64a-226e-0266-e053-dadaa90a7c1a72ce6aea-6cfc-4a6b-8d5d-1466adf5745e

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3139-07051831390030 TABLET in 1 BLISTER PACK (70518-3139-0) 30 tablet2021-07-020000-00-00NoNoCurrent