LAMOTRIGINE

Product NDC
76519-1151
11-digit product format
765191151
Labeler code
76519
Product ID
76519-1151_839e9c4c-bff9-fda2-e053-2a91aa0a9be4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LAMOTRIGINE
Dosage form
TABLET
Route
ORAL
Labeler
H. J. Harkins Company Inc.
Application
ANDA077783
Marketing category
ANDA
Marketing start
2017-02-16
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
2020-12-31
Current FDA listing
Historical FDA.report record

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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct76519-1151IInactivated by FDA2026-10-05
excluded packagepackage76519-115176519-1151-1IInactivated by FDA2026-10-05
excluded packagepackage76519-115176519-1151-3IInactivated by FDA2026-10-05
excluded packagepackage76519-115176519-1151-6IInactivated by FDA2026-10-05
excluded packagepackage76519-115176519-1151-9IInactivated by FDA2026-10-05

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 2 · 90 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 packagepackage76519-1151-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage76519-1151-6d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage76519-1151-9d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage76519-1151-3d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage76519-1151-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage76519-1151-6f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage76519-1151-9f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage76519-1151-3f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage76519-1151-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage76519-1151-62ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage76519-1151-92ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage76519-1151-32ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage76519-1151-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage76519-1151-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage76519-1151-9a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage76519-1151-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage76519-1151-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage76519-1151-6cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage76519-1151-9cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage76519-1151-3cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage76519-1151-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage76519-1151-6cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage76519-1151-9cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage76519-1151-3cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage76519-1151-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage76519-1151-6302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage76519-1151-9302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage76519-1151-3302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage76519-1151-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage76519-1151-6ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage76519-1151-9ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage76519-1151-3ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage76519-1151-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage76519-1151-60efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage76519-1151-90efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage76519-1151-30efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage76519-1151-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage76519-1151-6ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage76519-1151-9ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage76519-1151-3ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage76519-1151-1367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage76519-1151-6367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage76519-1151-9367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage76519-1151-3367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage76519-1151-1557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage76519-1151-6557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage76519-1151-9557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage76519-1151-3557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A077783-001LAMOTRIGINELAMOTRIGINE25MGTABLET / ORAL2010-11-01
A077783-002LAMOTRIGINELAMOTRIGINE100MGTABLET / ORAL2010-11-01
A077783-003LAMOTRIGINELAMOTRIGINE150MGTABLET / ORAL2010-11-01
A077783-004LAMOTRIGINELAMOTRIGINE200MGTABLET / ORAL2010-11-01

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 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077783-001LAMOTRIGINE25MGTABLET / ORAL2010-11-0184e616aacf4f…
2026-09-14 22:38:342026-08A077783-002LAMOTRIGINE100MGTABLET / ORAL2010-11-0184e616aacf4f…
2026-09-14 22:38:342026-08A077783-003LAMOTRIGINE150MGTABLET / ORAL2010-11-0184e616aacf4f…
2026-09-14 22:38:342026-08A077783-004LAMOTRIGINE200MGTABLET / ORAL2010-11-0184e616aacf4f…
2026-08-18 06:07:402026-07A077783-001LAMOTRIGINE25MGTABLET / ORAL2010-11-01caaa826d4ba7…
2026-08-18 06:07:402026-07A077783-002LAMOTRIGINE100MGTABLET / ORAL2010-11-01caaa826d4ba7…
2026-08-18 06:07:402026-07A077783-003LAMOTRIGINE150MGTABLET / ORAL2010-11-01caaa826d4ba7…
2026-08-18 06:07:402026-07A077783-004LAMOTRIGINE200MGTABLET / ORAL2010-11-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077783-001LAMOTRIGINE25MGTABLET / ORAL2010-11-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077783-002LAMOTRIGINE100MGTABLET / ORAL2010-11-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077783-003LAMOTRIGINE150MGTABLET / ORAL2010-11-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077783-004LAMOTRIGINE200MGTABLET / ORAL2010-11-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077783-001LAMOTRIGINE25MGTABLET / ORAL2010-11-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077783-002LAMOTRIGINE100MGTABLET / ORAL2010-11-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077783-003LAMOTRIGINE150MGTABLET / ORAL2010-11-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077783-004LAMOTRIGINE200MGTABLET / ORAL2010-11-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077783-001LAMOTRIGINE25MGTABLET / ORAL2010-11-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077783-002LAMOTRIGINE100MGTABLET / ORAL2010-11-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077783-003LAMOTRIGINE150MGTABLET / ORAL2010-11-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077783-004LAMOTRIGINE200MGTABLET / ORAL2010-11-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077783-001LAMOTRIGINE25MGTABLET / ORAL2010-11-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077783-002LAMOTRIGINE100MGTABLET / ORAL2010-11-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077783-003LAMOTRIGINE150MGTABLET / ORAL2010-11-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077783-004LAMOTRIGINE200MGTABLET / ORAL2010-11-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077783-001LAMOTRIGINE25MGTABLET / ORAL2010-11-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077783-002LAMOTRIGINE100MGTABLET / ORAL2010-11-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077783-003LAMOTRIGINE150MGTABLET / ORAL2010-11-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077783-004LAMOTRIGINE200MGTABLET / ORAL2010-11-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077783-001LAMOTRIGINE25MGTABLET / ORAL2010-11-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077783-002LAMOTRIGINE100MGTABLET / ORAL2010-11-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077783-003LAMOTRIGINE150MGTABLET / ORAL2010-11-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077783-004LAMOTRIGINE200MGTABLET / ORAL2010-11-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077783-001LAMOTRIGINE25MGTABLET / ORAL2010-11-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077783-002LAMOTRIGINE100MGTABLET / ORAL2010-11-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077783-003LAMOTRIGINE150MGTABLET / ORAL2010-11-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077783-004LAMOTRIGINE200MGTABLET / ORAL2010-11-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077783-001LAMOTRIGINE25MGTABLET / ORAL2010-11-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077783-002LAMOTRIGINE100MGTABLET / ORAL2010-11-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077783-003LAMOTRIGINE150MGTABLET / ORAL2010-11-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077783-004LAMOTRIGINE200MGTABLET / ORAL2010-11-015bbf6a4d5a75…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A077783-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077783-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077783-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077783-004AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A077783-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A077783-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A077783-003AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A077783-004AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A077783-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077783-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077783-003AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077783-004AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077783-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077783-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077783-003AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077783-004AB1ea99ee380514…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76519-1151-1LAMOTRIGINE100 in 1 CONTAINERTABLET1002
76519-1151-3LAMOTRIGINE30 in 1 CONTAINERTABLET302
76519-1151-6LAMOTRIGINE60 in 1 CONTAINERTABLET602
76519-1151-9LAMOTRIGINE90 in 1 CONTAINERTABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76519-1151LAMOTRIGINE TABLET [H. J. HARKINS COMPANY INC.]2Legacy NDC, 4 package rows20190312_60f3672f-4ca3-17ea-e053-2991aa0a6b5e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198427lamoTRIgine 100 MG Oral TabletPSN60f3672f-4ca3-17ea-e053-2991aa0a6b5e2
198429lamoTRIgine 200 MG Oral TabletPSN60f3672f-4ca3-17ea-e053-2991aa0a6b5e2
282401lamoTRIgine 25 MG Oral TabletPSN60f3672f-4ca3-17ea-e053-2991aa0a6b5e2
198427lamotrigine 100 MG Oral TabletSCD60f3672f-4ca3-17ea-e053-2991aa0a6b5e2
198429lamotrigine 200 MG Oral TabletSCD60f3672f-4ca3-17ea-e053-2991aa0a6b5e2
282401lamotrigine 25 MG Oral TabletSCD60f3672f-4ca3-17ea-e053-2991aa0a6b5e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76519-1151-176519115101100 TABLET in 1 CONTAINER (76519-1151-1) 100 tablet2017-02-160000-00-00NoNoCurrent
76519-1151-37651911510330 TABLET in 1 CONTAINER (76519-1151-3) 30 tablet2017-02-160000-00-00NoNoCurrent
76519-1151-67651911510660 TABLET in 1 CONTAINER (76519-1151-6) 60 tablet2017-02-160000-00-00NoNoCurrent
76519-1151-97651911510990 TABLET in 1 CONTAINER (76519-1151-9) 90 tablet2017-02-160000-00-00NoNoCurrent