Lamotrigine Extended Release

Product NDC
52817-242
11-digit product format
528170242
Labeler code
52817
Product ID
52817-242_9f02e5fb-2921-5bc7-e053-2a95a90ae9e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lamotrigine extended release
Dosage form
TABLET
Route
ORAL
Labeler
TruPharma, LLC
Application
ANDA202887
Marketing category
ANDA
Marketing start
2017-06-05
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
2021-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52817-242IInactivated by FDA2026-10-05
excluded packagepackage52817-24252817-242-30IInactivated 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 1 · 30 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 packagepackage52817-242-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52817-242-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52817-242-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52817-242-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52817-242-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52817-242-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52817-242-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52817-242-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52817-242-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52817-242-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52817-242-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52817-242-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage52817-242-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage52817-242-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage52817-242-301332a3947898…d4bfe170f9cd…

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
A202887-001LAMOTRIGINELAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORAL2013-06-17
A202887-002LAMOTRIGINELAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORAL2013-06-17
A202887-003LAMOTRIGINELAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2013-06-17
A202887-004LAMOTRIGINELAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORALAB2013-06-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202887-003AB
A202887-004AB

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 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A202887-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORAL2013-06-1784e616aacf4f…
2026-09-14 22:38:342026-08A202887-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORAL2013-06-1784e616aacf4f…
2026-09-14 22:38:342026-08A202887-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2013-06-1784e616aacf4f…
2026-09-14 22:38:342026-08A202887-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORALAB2013-06-1784e616aacf4f…
2026-08-18 06:07:402026-07A202887-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORAL2013-06-17caaa826d4ba7…
2026-08-18 06:07:402026-07A202887-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORAL2013-06-17caaa826d4ba7…
2026-08-18 06:07:402026-07A202887-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2013-06-17caaa826d4ba7…
2026-08-18 06:07:402026-07A202887-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORALAB2013-06-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202887-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORAL2013-06-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202887-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORAL2013-06-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202887-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2013-06-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202887-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORALAB2013-06-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202887-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORAL2013-06-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202887-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORAL2013-06-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202887-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2013-06-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202887-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORALAB2013-06-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A202887-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORAL2013-06-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202887-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORAL2013-06-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202887-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2013-06-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202887-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORALAB2013-06-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202887-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORAL2013-06-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202887-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORAL2013-06-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202887-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2013-06-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202887-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORALAB2013-06-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202887-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORAL2013-06-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202887-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORAL2013-06-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202887-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2013-06-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202887-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORALAB2013-06-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202887-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORAL2013-06-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202887-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORAL2013-06-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202887-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2013-06-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202887-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORALAB2013-06-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202887-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORAL2013-06-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202887-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORAL2013-06-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202887-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2013-06-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202887-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORALAB2013-06-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202887-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORAL2013-06-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202887-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORAL2013-06-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202887-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2013-06-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202887-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORALAB2013-06-175bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A202887-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A202887-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A202887-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202887-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202887-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202887-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202887-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202887-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202887-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202887-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202887-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202887-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202887-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202887-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202887-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202887-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202887-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202887-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202887-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202887-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202887-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202887-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202887-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202887-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202887-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202887-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202887-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202887-004AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202887-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202887-004AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202887-003AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202887-004AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202887-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202887-004AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202887-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202887-004AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202887-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202887-004AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202887-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202887-004AB174a2ff9319b5…

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
52817-242-30Lamotrigine Extended Release30 in 1 BOTTLETABLET303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52817-242-30EA - Each52817-242ef3d39dd-bb64-4355-92b9-a6d32960f45812017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52817-242LAMOTRIGINE EXTENDED RELEASE TABLET [TRUPHARMA, LLC]3Legacy NDC, 1 package rows20200221_9e154d39-8437-4ea9-8c7c-3fbff6fd1ddf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
850087lamoTRIgine 100 MG 24HR Extended Release Oral TabletPSN9e154d39-8437-4ea9-8c7c-3fbff6fd1ddf3
900156lamoTRIgine 200 MG 24HR Extended Release Oral TabletPSN9e154d39-8437-4ea9-8c7c-3fbff6fd1ddf3
900164lamoTRIgine 25 MG 24HR Extended Release Oral TabletPSN9e154d39-8437-4ea9-8c7c-3fbff6fd1ddf3
850091lamoTRIgine 50 MG 24HR Extended Release Oral TabletPSN9e154d39-8437-4ea9-8c7c-3fbff6fd1ddf3
85008724 HR lamotrigine 100 MG Extended Release Oral TabletSCD9e154d39-8437-4ea9-8c7c-3fbff6fd1ddf3
90015624 HR lamotrigine 200 MG Extended Release Oral TabletSCD9e154d39-8437-4ea9-8c7c-3fbff6fd1ddf3
90016424 HR lamotrigine 25 MG Extended Release Oral TabletSCD9e154d39-8437-4ea9-8c7c-3fbff6fd1ddf3
85009124 HR lamotrigine 50 MG Extended Release Oral TabletSCD9e154d39-8437-4ea9-8c7c-3fbff6fd1ddf3
850087lamotrigine 100 MG 24 HR Extended Release Oral TabletSY9e154d39-8437-4ea9-8c7c-3fbff6fd1ddf3
900156lamotrigine 200 MG 24 HR Extended Release Oral TabletSY9e154d39-8437-4ea9-8c7c-3fbff6fd1ddf3
900164lamotrigine 25 MG 24 HR Extended Release Oral TabletSY9e154d39-8437-4ea9-8c7c-3fbff6fd1ddf3
850091lamotrigine 50 MG 24 HR Extended Release Oral TabletSY9e154d39-8437-4ea9-8c7c-3fbff6fd1ddf3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52817-242-305281702423030 TABLET in 1 BOTTLE (52817-242-30) 30 tablet2017-06-050000-00-00NoNoCurrent