Lamotrigine

Product NDC
68462-245
11-digit product format
684620245
Labeler code
68462
Product ID
68462-245_7c5834f5-1006-4617-97a5-9920dec7b847
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA090169
Marketing category
ANDA
Marketing start
2012-05-04
Marketing end
0000-00-00
Substance
LAMOTRIGINE
Active strength
150 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
2019-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68462-245DDiscontinued by firm2026-10-12
excluded packagepackage68462-24568462-245-10DDiscontinued by firm2026-10-12
excluded packagepackage68462-24568462-245-30DDiscontinued by firm2026-10-12
excluded packagepackage68462-24568462-245-60DDiscontinued by firm2026-10-12

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 · 48 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 packagepackage68462-245-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68462-245-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68462-245-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68462-245-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68462-245-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68462-245-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68462-245-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68462-245-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68462-245-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68462-245-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68462-245-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68462-245-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68462-245-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68462-245-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68462-245-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68462-245-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68462-245-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68462-245-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68462-245-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68462-245-60302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68462-245-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68462-245-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68462-245-60ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68462-245-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68462-245-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68462-245-600efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68462-245-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68462-245-10ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68462-245-60ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68462-245-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68462-245-10367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68462-245-60367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68462-245-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68462-245-10557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68462-245-60557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68462-245-30557ba5c1ecfa…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
A090169-001LAMOTRIGINELAMOTRIGINE25MGTABLET / ORALAB2012-05-04
A090169-002LAMOTRIGINELAMOTRIGINE100MGTABLET / ORALAB2012-05-04
A090169-003LAMOTRIGINELAMOTRIGINE150MGTABLET / ORALAB2012-05-04
A090169-004LAMOTRIGINELAMOTRIGINE200MGTABLET / ORALAB2012-05-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090169-001AB
A090169-002AB
A090169-003AB
A090169-004AB

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 22:38:342026-08A090169-001LAMOTRIGINE25MGTABLET / ORALAB2012-05-0484e616aacf4f…
2026-09-14 22:38:342026-08A090169-002LAMOTRIGINE100MGTABLET / ORALAB2012-05-0484e616aacf4f…
2026-09-14 22:38:342026-08A090169-003LAMOTRIGINE150MGTABLET / ORALAB2012-05-0484e616aacf4f…
2026-09-14 22:38:342026-08A090169-004LAMOTRIGINE200MGTABLET / ORALAB2012-05-0484e616aacf4f…
2026-08-18 06:07:402026-07A090169-001LAMOTRIGINE25MGTABLET / ORALAB2012-05-04caaa826d4ba7…
2026-08-18 06:07:402026-07A090169-002LAMOTRIGINE100MGTABLET / ORALAB2012-05-04caaa826d4ba7…
2026-08-18 06:07:402026-07A090169-003LAMOTRIGINE150MGTABLET / ORALAB2012-05-04caaa826d4ba7…
2026-08-18 06:07:402026-07A090169-004LAMOTRIGINE200MGTABLET / ORALAB2012-05-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090169-001LAMOTRIGINE25MGTABLET / ORALAB2012-05-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090169-002LAMOTRIGINE100MGTABLET / ORALAB2012-05-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090169-003LAMOTRIGINE150MGTABLET / ORALAB2012-05-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090169-004LAMOTRIGINE200MGTABLET / ORALAB2012-05-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090169-001LAMOTRIGINE25MGTABLET / ORALAB2012-05-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090169-002LAMOTRIGINE100MGTABLET / ORALAB2012-05-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090169-003LAMOTRIGINE150MGTABLET / ORALAB2012-05-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090169-004LAMOTRIGINE200MGTABLET / ORALAB2012-05-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A090169-001LAMOTRIGINE25MGTABLET / ORALAB2012-05-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090169-002LAMOTRIGINE100MGTABLET / ORALAB2012-05-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090169-003LAMOTRIGINE150MGTABLET / ORALAB2012-05-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090169-004LAMOTRIGINE200MGTABLET / ORALAB2012-05-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090169-001LAMOTRIGINE25MGTABLET / ORALAB2012-05-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090169-002LAMOTRIGINE100MGTABLET / ORALAB2012-05-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090169-003LAMOTRIGINE150MGTABLET / ORALAB2012-05-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090169-004LAMOTRIGINE200MGTABLET / ORALAB2012-05-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090169-001LAMOTRIGINE25MGTABLET / ORALAB2012-05-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090169-002LAMOTRIGINE100MGTABLET / ORALAB2012-05-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090169-003LAMOTRIGINE150MGTABLET / ORALAB2012-05-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090169-004LAMOTRIGINE200MGTABLET / ORALAB2012-05-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090169-001LAMOTRIGINE25MGTABLET / ORALAB2012-05-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090169-002LAMOTRIGINE100MGTABLET / ORALAB2012-05-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090169-003LAMOTRIGINE150MGTABLET / ORALAB2012-05-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090169-004LAMOTRIGINE200MGTABLET / ORALAB2012-05-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090169-001LAMOTRIGINE25MGTABLET / ORALAB2012-05-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090169-002LAMOTRIGINE100MGTABLET / ORALAB2012-05-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090169-003LAMOTRIGINE150MGTABLET / ORALAB2012-05-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090169-004LAMOTRIGINE200MGTABLET / ORALAB2012-05-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090169-001LAMOTRIGINE25MGTABLET / ORALAB2012-05-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090169-002LAMOTRIGINE100MGTABLET / ORALAB2012-05-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090169-003LAMOTRIGINE150MGTABLET / ORALAB2012-05-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090169-004LAMOTRIGINE200MGTABLET / ORALAB2012-05-045bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A090169-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A090169-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A090169-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A090169-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A090169-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090169-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090169-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090169-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090169-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090169-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090169-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090169-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090169-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090169-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090169-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090169-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090169-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090169-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090169-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090169-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090169-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090169-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090169-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090169-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090169-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090169-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090169-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090169-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090169-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090169-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090169-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090169-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090169-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090169-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090169-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090169-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090169-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090169-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090169-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090169-004AB15bbf6a4d5a75…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-245-60EA - Each68462-2452185a57b-3b58-4acc-9ef1-8b4204e83e4812013-03-03