Lamotrigine

Product NDC
0115-9939
11-digit product format
001159939
Labeler code
0115
Product ID
0115-9939_813e9f35-df9e-428a-9f4f-1a312c86f937
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LAMOTRIGINE
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA200828
Marketing category
ANDA
Marketing start
2018-12-27
Substance
LAMOTRIGINE
Active strength
25 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
2026-12-31
Current FDA listing
Yes

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 · 8 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0115-9939-08557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage0115-9939-088af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage0115-9939-08834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage0115-9939-081332a3947898…d4bfe170f9cd…

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
A200828-001LAMOTRIGINELAMOTRIGINE25MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-07-15
A200828-002LAMOTRIGINELAMOTRIGINE50MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-07-15
A200828-003LAMOTRIGINELAMOTRIGINE100MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-07-15
A200828-004LAMOTRIGINELAMOTRIGINE200MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-07-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A200828-001AB
A200828-002AB
A200828-003AB
A200828-004AB

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 UTC2026-02A200828-001LAMOTRIGINE25MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-07-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200828-002LAMOTRIGINE50MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-07-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200828-003LAMOTRIGINE100MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-07-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200828-004LAMOTRIGINE200MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-07-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200828-001LAMOTRIGINE25MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-07-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200828-002LAMOTRIGINE50MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-07-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200828-003LAMOTRIGINE100MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-07-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200828-004LAMOTRIGINE200MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-07-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A200828-001LAMOTRIGINE25MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-07-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200828-002LAMOTRIGINE50MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-07-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200828-003LAMOTRIGINE100MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-07-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200828-004LAMOTRIGINE200MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-07-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200828-001LAMOTRIGINE25MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-07-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200828-002LAMOTRIGINE50MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-07-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200828-003LAMOTRIGINE100MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-07-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200828-004LAMOTRIGINE200MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-07-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200828-001LAMOTRIGINE25MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-07-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200828-002LAMOTRIGINE50MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-07-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200828-003LAMOTRIGINE100MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-07-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200828-004LAMOTRIGINE200MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-07-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200828-001LAMOTRIGINE25MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-07-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200828-002LAMOTRIGINE50MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-07-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200828-003LAMOTRIGINE100MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-07-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200828-004LAMOTRIGINE200MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-07-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200828-001LAMOTRIGINE25MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-07-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200828-002LAMOTRIGINE50MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-07-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200828-003LAMOTRIGINE100MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-07-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200828-004LAMOTRIGINE200MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-07-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200828-001LAMOTRIGINE25MGTABLET, ORALLY DISINTEGRATING / ORAL2013-07-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200828-002LAMOTRIGINE50MGTABLET, ORALLY DISINTEGRATING / ORAL2013-07-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200828-003LAMOTRIGINE100MGTABLET, ORALLY DISINTEGRATING / ORAL2013-07-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200828-004LAMOTRIGINE200MGTABLET, ORALLY DISINTEGRATING / ORAL2013-07-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200828-001LAMOTRIGINE25MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-07-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200828-002LAMOTRIGINE50MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-07-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200828-003LAMOTRIGINE100MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-07-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200828-004LAMOTRIGINE200MGTABLET, ORALLY DISINTEGRATING / ORALAB2013-07-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200828-001LAMOTRIGINE25MGTABLET, ORALLY DISINTEGRATING / ORAL2013-07-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A200828-002LAMOTRIGINE50MGTABLET, ORALLY DISINTEGRATING / ORAL2013-07-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A200828-003LAMOTRIGINE100MGTABLET, ORALLY DISINTEGRATING / ORAL2013-07-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A200828-004LAMOTRIGINE200MGTABLET, ORALLY DISINTEGRATING / ORAL2013-07-15d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A200828-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200828-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200828-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200828-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200828-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200828-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200828-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200828-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A200828-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200828-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200828-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200828-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200828-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200828-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200828-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200828-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200828-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200828-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200828-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200828-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200828-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200828-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200828-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200828-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200828-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200828-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200828-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200828-004AB12680178bc6a6…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200828-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200828-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200828-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200828-004AB1d8e5a09893c0…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200828-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200828-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200828-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200828-004AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200828-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A200828-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A200828-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A200828-004AB15d02ea3f76ae…

Additional Listing Data#

Finished product
Yes
Brand name base
Lamotrigine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LAMOTRIGINE25 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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
103968Internal RxNorm lookup
198430Internal RxNorm lookup
252478Internal RxNorm lookup
252479Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9e5c2d76-47a6-4a57-b23c-2398b307380cAvailable 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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-09-19These highlights do not include all the information needed to use LAMOTRIGINE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE ORALLY DISINTEGRATING TABLETS. LAMOTRIGINE orally disintegrating tablets, for oral use Initial U.S. Approval: 1994
2023-01-30These highlights do not include all the information needed to use LAMOTRIGINE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE ORALLY DISINTEGRATING TABLETS. LAMOTRIGINE orally disintegrating tablets, for oral use Initial U.S. Approval: 1994
2020-11-24These highlights do not include all the information needed to use LAMOTRIGINE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE ORALLY DISINTEGRATING TABLETS. LAMOTRIGINE orally disintegrating tablets, for oral use Initial U.S. Approval: 1994
2020-09-27These highlights do not include all the information needed to use LAMOTRIGINE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE ORALLY DISINTEGRATING TABLETS. LAMOTRIGINE orally disintegrating tablets, for oral use Initial U.S. Approval: 1994
2020-09-25These highlights do not include all the information needed to use LAMOTRIGINE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE ORALLY DISINTEGRATING TABLETS. LAMOTRIGINE orally disintegrating tablets, for oral use Initial U.S. Approval: 1994
2020-07-22These highlights do not include all the information needed to use LAMOTRIGINE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE ORALLY DISINTEGRATING TABLETS. LAMOTRIGINE orally disintegrating tablets, for oral use Initial U.S. Approval: 1994

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0115-9939-01Lamotrigine30 in 1 BOTTLETABLET, ORALLY DISINTEGRATING3014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-9939-01EA - Each0115-993973a1d9e1-7bd8-4585-b08f-a985df2af6fb12025-02-10
0115-9939-08EA - Each0115-993960c4fbed-4112-48ce-b0b5-b911720072dc12019-05-02
0115-9939-68EA - Each0115-9939128a09cc-1386-4dc7-9134-c1a3b384d2d412019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-9939LAMOTRIGINE TABLET, ORALLY DISINTEGRATING [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]12Current NDC, Legacy NDC, 1 package rows20241024_9e5c2d76-47a6-4a57-b23c-2398b307380c.zip

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LamotrigineLAMOTRIGINEAmneal Pharmaceuticals of New York LLC9e5c2d76-47a6-4a57-b23c-2398b307380c2025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200828
application number: ANDA200828
ndc (product): 0115-9939
LamotrigineLAMOTRIGINEAmneal Pharmaceuticals of New York LLC380bddae-5b31-4965-96de-97711d859d112016-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200828
application number: ANDA200828

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103968lamoTRIgine 100 MG Disintegrating Oral TabletPSN9e5c2d76-47a6-4a57-b23c-2398b307380c14
252479lamoTRIgine 200 MG Disintegrating Oral TabletPSN9e5c2d76-47a6-4a57-b23c-2398b307380c14
198430lamoTRIgine 25 MG Disintegrating Oral TabletPSN9e5c2d76-47a6-4a57-b23c-2398b307380c14
252478lamoTRIgine 50 MG Disintegrating Oral TabletPSN9e5c2d76-47a6-4a57-b23c-2398b307380c14
103968lamotrigine 100 MG Disintegrating Oral TabletSCD9e5c2d76-47a6-4a57-b23c-2398b307380c14
252479lamotrigine 200 MG Disintegrating Oral TabletSCD9e5c2d76-47a6-4a57-b23c-2398b307380c14
198430lamotrigine 25 MG Disintegrating Oral TabletSCD9e5c2d76-47a6-4a57-b23c-2398b307380c14
252478lamotrigine 50 MG Disintegrating Oral TabletSCD9e5c2d76-47a6-4a57-b23c-2398b307380c14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0115-9939-010011599390130 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (0115-9939-01) 2024-09-20NoNoCurrent
0115-9939-08001159939082 BLISTER PACK in 1 CARTON (0115-9939-08) > 15 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0115-9939-68) 2 blister pack2018-12-270000-00-00NoNoCurrent