Lamotrigine

Product NDC
0115-1529
11-digit product format
001151529
Labeler code
0115
Product ID
0115-1529_9611e358-6fe1-4f8d-99a2-250a7862a896
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
2015-01-09
Substance
LAMOTRIGINE
Active strength
200 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

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
LAMOTRIGINE200 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
380bddae-5b31-4965-96de-97711d859d11Available 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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
e29d8e8b-4bc8-ebaf-f18e-e35287b19d6aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0115-1529-08Lamotrigine3 in 1 CARTONTABLET, ORALLY DISINTEGRATING313
0115-1529-15Lamotrigine10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-1529-08EA - Each0115-15299f7caa64-a9ae-4ea3-9861-e19d4fa1520912015-03-03
0115-1529-15EA - Each0115-152900b08cab-8a0c-45f7-b9fc-448caa6991ad12018-05-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LAMOTRIGINEACTIVE INGREDIENTU3H27498KSLAMOTRIGINE TABLET, ORALLY DISINTEGRATING [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]1
LAMOTRIGINEACTIVE MOIETYU3H27498KSLAMOTRIGINE TABLET, ORALLY DISINTEGRATING [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]1
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1LAMOTRIGINE TABLET, ORALLY DISINTEGRATING [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULAMOTRIGINE TABLET, ORALLY DISINTEGRATING [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKLAMOTRIGINE TABLET, ORALLY DISINTEGRATING [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]1
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERINACTIVE INGREDIENT905HNO1SIHLAMOTRIGINE TABLET, ORALLY DISINTEGRATING [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAMOTRIGINE TABLET, ORALLY DISINTEGRATING [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ALAMOTRIGINE TABLET, ORALLY DISINTEGRATING [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LAMOTRIGINE TABLET, ORALLY DISINTEGRATING [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XLAMOTRIGINE TABLET, ORALLY DISINTEGRATING [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLAMOTRIGINE TABLET, ORALLY DISINTEGRATING [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APLAMOTRIGINE TABLET, ORALLY DISINTEGRATING [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-1529LAMOTRIGINE TABLET, ORALLY DISINTEGRATING [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]13Current NDC, Legacy NDC, 2 package rows20240101_380bddae-5b31-4965-96de-97711d859d11.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
LamotrigineLAMOTRIGINEAmneal Pharmaceuticals of New York LLC380bddae-5b31-4965-96de-97711d859d112016-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200828
application number: ANDA200828
ndc (product): 0115-1529

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103968lamoTRIgine 100 MG Disintegrating Oral TabletPSN380bddae-5b31-4965-96de-97711d859d1113
252479lamoTRIgine 200 MG Disintegrating Oral TabletPSN380bddae-5b31-4965-96de-97711d859d1113
198430lamoTRIgine 25 MG Disintegrating Oral TabletPSN380bddae-5b31-4965-96de-97711d859d1113
252478lamoTRIgine 50 MG Disintegrating Oral TabletPSN380bddae-5b31-4965-96de-97711d859d1113
103968lamotrigine 100 MG Disintegrating Oral TabletSCD380bddae-5b31-4965-96de-97711d859d1113
252479lamotrigine 200 MG Disintegrating Oral TabletSCD380bddae-5b31-4965-96de-97711d859d1113
198430lamotrigine 25 MG Disintegrating Oral TabletSCD380bddae-5b31-4965-96de-97711d859d1113
252478lamotrigine 50 MG Disintegrating Oral TabletSCD380bddae-5b31-4965-96de-97711d859d1113

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0115-1529-08001151529083 BLISTER PACK in 1 CARTON (0115-1529-08) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0115-1529-15) 3 blister pack2015-01-090000-00-00NoNoCurrent
0115-1529-150011515291510 in 1 BLISTER PACKHistorical