Lamotrigine

Product NDC
65841-690
11-digit product format
658410690
Labeler code
65841
Product ID
65841-690_c4eb074b-9cd4-4bcd-868c-473d9364061c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA078009
Marketing category
ANDA
Marketing start
2009-01-23
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078009-002LAMOTRIGINELAMOTRIGINE5MGTABLET, FOR SUSPENSION / ORALAB2009-01-22
A078009-003LAMOTRIGINELAMOTRIGINE25MGTABLET, FOR SUSPENSION / ORALAB2009-01-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A078009-002AB
A078009-003AB

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A078009-002LAMOTRIGINE5MGTABLET, FOR SUSPENSION / ORALAB2009-01-22caaa826d4ba7…
2026-08-18 06:07:402026-07A078009-003LAMOTRIGINE25MGTABLET, FOR SUSPENSION / ORALAB2009-01-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078009-002LAMOTRIGINE5MGTABLET, FOR SUSPENSION / ORALAB2009-01-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078009-003LAMOTRIGINE25MGTABLET, FOR SUSPENSION / ORALAB2009-01-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078009-002LAMOTRIGINE5MGTABLET, FOR SUSPENSION / ORALAB2009-01-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078009-003LAMOTRIGINE25MGTABLET, FOR SUSPENSION / ORALAB2009-01-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A078009-002LAMOTRIGINE5MGTABLET, FOR SUSPENSION / ORALAB2009-01-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078009-003LAMOTRIGINE25MGTABLET, FOR SUSPENSION / ORALAB2009-01-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078009-002LAMOTRIGINE5MGTABLET, FOR SUSPENSION / ORALAB2009-01-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078009-003LAMOTRIGINE25MGTABLET, FOR SUSPENSION / ORALAB2009-01-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078009-002LAMOTRIGINE5MGTABLET, FOR SUSPENSION / ORALAB2009-01-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078009-003LAMOTRIGINE25MGTABLET, FOR SUSPENSION / ORALAB2009-01-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078009-002LAMOTRIGINE5MGTABLET, FOR SUSPENSION / ORALAB2009-01-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078009-003LAMOTRIGINE25MGTABLET, FOR SUSPENSION / ORALAB2009-01-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078009-002LAMOTRIGINE5MGTABLET, FOR SUSPENSION / ORALAB2009-01-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078009-003LAMOTRIGINE25MGTABLET, FOR SUSPENSION / ORALAB2009-01-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078009-002LAMOTRIGINE5MGTABLET, FOR SUSPENSION / ORALAB2009-01-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078009-003LAMOTRIGINE25MGTABLET, FOR SUSPENSION / ORALAB2009-01-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078009-002LAMOTRIGINE5MGTABLET, FOR SUSPENSION / ORALAB2009-01-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078009-003LAMOTRIGINE25MGTABLET, FOR SUSPENSION / ORALAB2009-01-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078009-002LAMOTRIGINE5MGTABLET, FOR SUSPENSION / ORALAB2009-01-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A078009-003LAMOTRIGINE25MGTABLET, FOR SUSPENSION / ORALAB2009-01-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078009-002LAMOTRIGINE5MGTABLET, FOR SUSPENSION / ORALAB2009-01-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078009-003LAMOTRIGINE25MGTABLET, FOR SUSPENSION / ORALAB2009-01-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078009-002LAMOTRIGINE5MGTABLET, FOR SUSPENSION / ORALAB2009-01-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078009-003LAMOTRIGINE25MGTABLET, FOR SUSPENSION / ORALAB2009-01-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078009-002LAMOTRIGINE5MGTABLET, FOR SUSPENSION / ORALAB2009-01-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078009-003LAMOTRIGINE25MGTABLET, FOR SUSPENSION / ORALAB2009-01-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078009-002LAMOTRIGINE5MGTABLET, FOR SUSPENSION / ORALAB2009-01-228072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078009-003LAMOTRIGINE25MGTABLET, FOR SUSPENSION / ORALAB2009-01-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078009-002LAMOTRIGINE5MGTABLET, FOR SUSPENSION / ORALAB2009-01-225c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078009-003LAMOTRIGINE25MGTABLET, FOR SUSPENSION / ORALAB2009-01-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078009-002LAMOTRIGINE5MGTABLET, FOR SUSPENSION / ORALAB2009-01-225d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078009-003LAMOTRIGINE25MGTABLET, FOR SUSPENSION / ORALAB2009-01-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078009-002LAMOTRIGINE5MGTABLET, FOR SUSPENSION / ORALAB2009-01-224b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078009-003LAMOTRIGINE25MGTABLET, FOR SUSPENSION / ORALAB2009-01-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078009-002LAMOTRIGINE5MGTABLET, CHEWABLE / ORALAB2009-01-2274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078009-003LAMOTRIGINE25MGTABLET, CHEWABLE / ORALAB2009-01-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078009-002LAMOTRIGINE5MGTABLET, FOR SUSPENSION / ORALAB2009-01-22bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078009-003LAMOTRIGINE25MGTABLET, FOR SUSPENSION / ORALAB2009-01-22bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A078009-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078009-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078009-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078009-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078009-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078009-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078009-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078009-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078009-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078009-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078009-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078009-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078009-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078009-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078009-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078009-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078009-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078009-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078009-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078009-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078009-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078009-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078009-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078009-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078009-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078009-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078009-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078009-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078009-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078009-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078009-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078009-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078009-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078009-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078009-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078009-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078009-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078009-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078009-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078009-003AB1bb7c543d1eb4…

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 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198427Internal RxNorm lookup
198428Internal RxNorm lookup
198429Internal RxNorm lookup
199322Internal RxNorm lookup
249329Internal RxNorm lookup
282401Internal RxNorm lookup
311264Internal RxNorm lookup
311265Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0f2f7421-56d4-45d0-9d2d-dc1edaede039Available 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
65841-690-01Lamotrigine100 in 1 BOTTLETABLET, CHEWABLE10012
65841-690-05Lamotrigine500 in 1 BOTTLETABLET, CHEWABLE50012
65841-690-16Lamotrigine90 in 1 BOTTLETABLET, CHEWABLE9012

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LAMOTRIGINEACTIVE INGREDIENTU3H27498KSLAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [CADILA HEALTHCARE LIMITED]2
LAMOTRIGINEACTIVE MOIETYU3H27498KSLAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [CADILA HEALTHCARE LIMITED]2
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [CADILA HEALTHCARE LIMITED]2
BLACK CURRANTINACTIVE INGREDIENT9755T40D11LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [CADILA HEALTHCARE LIMITED]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [CADILA HEALTHCARE LIMITED]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [CADILA HEALTHCARE LIMITED]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [CADILA HEALTHCARE LIMITED]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [CADILA HEALTHCARE LIMITED]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ALAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [CADILA HEALTHCARE LIMITED]2
POVIDONEINACTIVE INGREDIENTFZ989GH94ELAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [CADILA HEALTHCARE LIMITED]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [CADILA HEALTHCARE LIMITED]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [CADILA HEALTHCARE LIMITED]2
TRIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENT91D9GV0Z28LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [CADILA HEALTHCARE LIMITED]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-690LAMOTRIGINE TABLET LAMOTRIGINE TABLET, CHEWABLE [ZYDUS LIFESCIENCES LIMITED]11Current NDC, Legacy NDC, 3 package rows20241204_0f2f7421-56d4-45d0-9d2d-dc1edaede039.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
LamotrigineLAMOTRIGINEZydus Pharmaceuticals USA Inc.e849033b-a3bc-408e-88de-7cd1d26609492025-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078009
application number: ANDA078009
LamotrigineLAMOTRIGINEZydus Lifesciences Limited0f2f7421-56d4-45d0-9d2d-dc1edaede0392025-10-04Exact identifier
application applno (ANDA): 078009
application number: ANDA078009
ndc (product): 65841-690

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198427lamoTRIgine 100 MG Oral TabletPSN0f2f7421-56d4-45d0-9d2d-dc1edaede03912
198428lamoTRIgine 150 MG Oral TabletPSN0f2f7421-56d4-45d0-9d2d-dc1edaede03912
198429lamoTRIgine 200 MG Oral TabletPSN0f2f7421-56d4-45d0-9d2d-dc1edaede03912
282401lamoTRIgine 25 MG Oral TabletPSN0f2f7421-56d4-45d0-9d2d-dc1edaede03912
311264lamoTRIgine 25 MG Tablet for Oral SuspensionPSN0f2f7421-56d4-45d0-9d2d-dc1edaede03912
249329lamoTRIgine 250 MG Oral TabletPSN0f2f7421-56d4-45d0-9d2d-dc1edaede03912
311265lamoTRIgine 5 MG Tablet for Oral SuspensionPSN0f2f7421-56d4-45d0-9d2d-dc1edaede03912
199322lamoTRIgine 50 MG Oral TabletPSN0f2f7421-56d4-45d0-9d2d-dc1edaede03912
198427lamotrigine 100 MG Oral TabletSCD0f2f7421-56d4-45d0-9d2d-dc1edaede03912
198428lamotrigine 150 MG Oral TabletSCD0f2f7421-56d4-45d0-9d2d-dc1edaede03912
198429lamotrigine 200 MG Oral TabletSCD0f2f7421-56d4-45d0-9d2d-dc1edaede03912
282401lamotrigine 25 MG Oral TabletSCD0f2f7421-56d4-45d0-9d2d-dc1edaede03912
311264lamotrigine 25 MG Tablet for Oral SuspensionSCD0f2f7421-56d4-45d0-9d2d-dc1edaede03912
249329lamotrigine 250 MG Oral TabletSCD0f2f7421-56d4-45d0-9d2d-dc1edaede03912
311265lamotrigine 5 MG Tablet for Oral SuspensionSCD0f2f7421-56d4-45d0-9d2d-dc1edaede03912
199322lamotrigine 50 MG Oral TabletSCD0f2f7421-56d4-45d0-9d2d-dc1edaede03912

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65841-690-0165841069001100 TABLET, CHEWABLE in 1 BOTTLE (65841-690-01) 2009-01-230000-00-00NoNoCurrent
65841-690-0565841069005500 TABLET, CHEWABLE in 1 BOTTLE (65841-690-05) 2009-01-230000-00-00NoNoCurrent
65841-690-166584106901690 TABLET, CHEWABLE in 1 BOTTLE (65841-690-16) 2009-01-230000-00-00NoNoCurrent