Lamotrigine

Product NDC
70518-1153
11-digit product format
705181153
Labeler code
70518
Product ID
70518-1153_50708c02-4ac2-2ebe-e063-6294a90ab303
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA203370
Marketing category
ANDA
Marketing start
2018-05-01
Substance
LAMOTRIGINE
Active strength
50 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-115370518-1153-0DDiscontinued by firm2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-1153-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-1153-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-1153-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-1153-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-1153-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-1153-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-1153-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-1153-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-1153-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-1153-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70518-1153-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70518-1153-0557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203370-001LAMOTRIGINELAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORALAB2013-12-23
A203370-002LAMOTRIGINELAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORALAB2013-12-23
A203370-003LAMOTRIGINELAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2013-12-23
A203370-004LAMOTRIGINELAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORAL2013-12-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A203370-001AB
A203370-002AB
A203370-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A203370-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORALAB2013-12-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203370-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORALAB2013-12-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203370-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2013-12-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203370-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORAL2013-12-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203370-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORALAB2013-12-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203370-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORALAB2013-12-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203370-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2013-12-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203370-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORAL2013-12-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A203370-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORALAB2013-12-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203370-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORALAB2013-12-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203370-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2013-12-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203370-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORAL2013-12-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203370-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORALAB2013-12-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203370-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORALAB2013-12-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203370-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2013-12-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203370-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORAL2013-12-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203370-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORALAB2013-12-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203370-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORALAB2013-12-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203370-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2013-12-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203370-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORAL2013-12-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203370-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORALAB2013-12-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203370-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORALAB2013-12-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203370-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2013-12-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203370-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORAL2013-12-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203370-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORALAB2013-12-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203370-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORALAB2013-12-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203370-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2013-12-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203370-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORAL2013-12-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203370-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORALAB2013-12-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203370-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORALAB2013-12-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203370-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2013-12-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203370-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORAL2013-12-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203370-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORALAB2013-12-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203370-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORALAB2013-12-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203370-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2013-12-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203370-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORAL2013-12-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203370-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORALAB2013-12-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A203370-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORALAB2013-12-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A203370-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2013-12-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A203370-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORAL2013-12-23d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 137 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A203370-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203370-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203370-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203370-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203370-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203370-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203370-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203370-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203370-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203370-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203370-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203370-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203370-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203370-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203370-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203370-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203370-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203370-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203370-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203370-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203370-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203370-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203370-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203370-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203370-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203370-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203370-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203370-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203370-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203370-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203370-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203370-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203370-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203370-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203370-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203370-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203370-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203370-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203370-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203370-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Lamotrigine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LAMOTRIGINE50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U3H27498KSInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
850091Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
de7f61ca-e3c0-4a09-b664-0df2de6a0c30Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
14a9502b-3d70-0496-a7e1-b16edaa005b8Product name520250423
16d731ed-ff3e-e9a1-3e3e-1ef6b6be40a0Product name720250401
e29d8e8b-4bc8-ebaf-f18e-e35287b19d6aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-1153-0Lamotrigine30 in 1 BLISTER PACKTABLET, EXTENDED RELEASE305
70518-1153-1Lamotrigine50 in 1 BOXTABLET, EXTENDED RELEASE505
70518-1153-2Lamotrigine1 in 1 POUCHTABLET, EXTENDED RELEASE15

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LamotrigineLAMOTRIGINEREMEDYREPACK INC.de7f61ca-e3c0-4a09-b664-0df2de6a0c302026-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203370
application number: ANDA203370
ndc (product): 70518-1153
LamotrigineLAMOTRIGINETorrent Pharmaceuticals Limited52df02a7-83da-4b20-9951-69790237dc242026-03-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203370
application number: ANDA203370
LamotrigineLAMOTRIGINEProficient Rx LPffa46cb2-16e7-45f3-9940-5cb88d0cda9d2024-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203370
application number: ANDA203370

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
850091lamoTRIgine 50 MG 24HR Extended Release Oral TabletPSNde7f61ca-e3c0-4a09-b664-0df2de6a0c305
85009124 HR lamotrigine 50 MG Extended Release Oral TabletSCDde7f61ca-e3c0-4a09-b664-0df2de6a0c305
850091lamotrigine 50 MG 24 HR Extended Release Oral TabletSYde7f61ca-e3c0-4a09-b664-0df2de6a0c305

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-1153-07051811530030 in 1 BLISTER PACKHistorical
70518-1153-17051811530150 POUCH in 1 BOX (70518-1153-1) / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-1153-2) 50 pouch2026-04-24NoNoCurrent
70518-1153-2705181153021 in 1 POUCHHistorical