Lamotrigine Extended Release

Product NDC
49884-604
11-digit product format
498840604
Labeler code
49884
Product ID
49884-604_3c26caa3-84f9-442d-b752-9dda35d0bacb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lamotrigine extended release
Dosage form
TABLET
Route
ORAL
Labeler
Par Pharmaceutical, Inc.
Application
ANDA201791
Marketing category
ANDA
Marketing start
2013-01-18
Marketing end
0000-00-00
Substance
LAMOTRIGINE
Active strength
250 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
2022-12-31
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 productproduct49884-604DDiscontinued by firm2026-10-16
excluded packagepackage49884-60449884-604-01DDiscontinued by firm2026-10-16
excluded packagepackage49884-60449884-604-05DDiscontinued by firm2026-10-16
excluded packagepackage49884-60449884-604-11DDiscontinued by firm2026-10-16

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A201791-001LAMOTRIGINELAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORAL2013-01-18
A201791-002LAMOTRIGINELAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORAL2013-01-18
A201791-003LAMOTRIGINELAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORAL2013-01-18
A201791-004LAMOTRIGINELAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORAL2013-01-18
A201791-005LAMOTRIGINELAMOTRIGINE250MGTABLET, EXTENDED RELEASE / ORAL2013-01-18
A201791-006LAMOTRIGINELAMOTRIGINE300MGTABLET, EXTENDED RELEASE / ORAL2013-01-18

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 7 · 264 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A201791-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORAL2013-01-18c2088c7a36db…
2026-10-15 13:18:302026-09A201791-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORAL2013-01-18c2088c7a36db…
2026-10-15 13:18:302026-09A201791-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORAL2013-01-18c2088c7a36db…
2026-10-15 13:18:302026-09A201791-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORAL2013-01-18c2088c7a36db…
2026-10-15 13:18:302026-09A201791-005LAMOTRIGINE250MGTABLET, EXTENDED RELEASE / ORAL2013-01-18c2088c7a36db…
2026-10-15 13:18:302026-09A201791-006LAMOTRIGINE300MGTABLET, EXTENDED RELEASE / ORAL2013-01-18c2088c7a36db…
2026-09-14 22:38:342026-08A201791-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORAL2013-01-1884e616aacf4f…
2026-09-14 22:38:342026-08A201791-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORAL2013-01-1884e616aacf4f…
2026-09-14 22:38:342026-08A201791-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORAL2013-01-1884e616aacf4f…
2026-09-14 22:38:342026-08A201791-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORAL2013-01-1884e616aacf4f…
2026-09-14 22:38:342026-08A201791-005LAMOTRIGINE250MGTABLET, EXTENDED RELEASE / ORAL2013-01-1884e616aacf4f…
2026-09-14 22:38:342026-08A201791-006LAMOTRIGINE300MGTABLET, EXTENDED RELEASE / ORAL2013-01-1884e616aacf4f…
2026-08-18 06:07:402026-07A201791-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORAL2013-01-18caaa826d4ba7…
2026-08-18 06:07:402026-07A201791-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORAL2013-01-18caaa826d4ba7…
2026-08-18 06:07:402026-07A201791-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORAL2013-01-18caaa826d4ba7…
2026-08-18 06:07:402026-07A201791-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORAL2013-01-18caaa826d4ba7…
2026-08-18 06:07:402026-07A201791-005LAMOTRIGINE250MGTABLET, EXTENDED RELEASE / ORAL2013-01-18caaa826d4ba7…
2026-08-18 06:07:402026-07A201791-006LAMOTRIGINE300MGTABLET, EXTENDED RELEASE / ORAL2013-01-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A201791-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORALAB2013-01-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201791-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORALAB2013-01-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201791-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2013-01-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201791-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORALAB2013-01-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201791-005LAMOTRIGINE250MGTABLET, EXTENDED RELEASE / ORALAB2013-01-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201791-006LAMOTRIGINE300MGTABLET, EXTENDED RELEASE / ORALAB2013-01-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201791-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORALAB2013-01-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201791-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORALAB2013-01-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201791-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2013-01-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201791-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORALAB2013-01-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201791-005LAMOTRIGINE250MGTABLET, EXTENDED RELEASE / ORALAB2013-01-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201791-006LAMOTRIGINE300MGTABLET, EXTENDED RELEASE / ORALAB2013-01-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A201791-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORALAB2013-01-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201791-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORALAB2013-01-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201791-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2013-01-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201791-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORALAB2013-01-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201791-005LAMOTRIGINE250MGTABLET, EXTENDED RELEASE / ORALAB2013-01-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201791-006LAMOTRIGINE300MGTABLET, EXTENDED RELEASE / ORALAB2013-01-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201791-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORALAB2013-01-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201791-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORALAB2013-01-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201791-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2013-01-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201791-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORALAB2013-01-18fd3edfee7708…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 6 · 240 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201791-005AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201791-006AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201791-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201791-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201791-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201791-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201791-005AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201791-006AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201791-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201791-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201791-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201791-004AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201791-005AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201791-006AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201791-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A201791-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A201791-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A201791-004AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A201791-005AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A201791-006AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201791-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201791-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201791-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201791-004AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201791-005AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201791-006AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201791-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201791-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201791-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201791-004AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201791-005AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201791-006AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201791-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201791-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201791-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201791-004AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201791-005AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201791-006AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201791-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A201791-002AB18072bd15b7f6…

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49884-604-01Lamotrigine Extended Release100 in 1 BOTTLETABLET10021
49884-604-05Lamotrigine Extended Release500 in 1 BOTTLETABLET50021
49884-604-11Lamotrigine Extended Release30 in 1 BOTTLETABLET3021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-604-11EA - Each49884-60418bd48db-989c-409d-a439-4567a250038b12013-02-13

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49884-604LAMOTRIGINE EXTENDED RELEASE TABLET [ENDO USA, INC.]15Legacy NDC, 3 package rows20240913_fb59c76a-9b6f-40ea-ac3a-58c3195c4377.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
850087lamoTRIgine 100 MG 24HR Extended Release Oral TabletPSNfb59c76a-9b6f-40ea-ac3a-58c3195c437721
900156lamoTRIgine 200 MG 24HR Extended Release Oral TabletPSNfb59c76a-9b6f-40ea-ac3a-58c3195c437721
900164lamoTRIgine 25 MG 24HR Extended Release Oral TabletPSNfb59c76a-9b6f-40ea-ac3a-58c3195c437721
1146690lamoTRIgine 250 MG 24HR Extended Release Oral TabletPSNfb59c76a-9b6f-40ea-ac3a-58c3195c437721
1098608lamoTRIgine 300 MG 24HR Extended Release Oral TabletPSNfb59c76a-9b6f-40ea-ac3a-58c3195c437721
850091lamoTRIgine 50 MG 24HR Extended Release Oral TabletPSNfb59c76a-9b6f-40ea-ac3a-58c3195c437721
85008724 HR lamotrigine 100 MG Extended Release Oral TabletSCDfb59c76a-9b6f-40ea-ac3a-58c3195c437721
90015624 HR lamotrigine 200 MG Extended Release Oral TabletSCDfb59c76a-9b6f-40ea-ac3a-58c3195c437721
90016424 HR lamotrigine 25 MG Extended Release Oral TabletSCDfb59c76a-9b6f-40ea-ac3a-58c3195c437721
114669024 HR lamotrigine 250 MG Extended Release Oral TabletSCDfb59c76a-9b6f-40ea-ac3a-58c3195c437721
109860824 HR lamotrigine 300 MG Extended Release Oral TabletSCDfb59c76a-9b6f-40ea-ac3a-58c3195c437721
85009124 HR lamotrigine 50 MG Extended Release Oral TabletSCDfb59c76a-9b6f-40ea-ac3a-58c3195c437721
850087lamotrigine 100 MG 24 HR Extended Release Oral TabletSYfb59c76a-9b6f-40ea-ac3a-58c3195c437721
900156lamotrigine 200 MG 24 HR Extended Release Oral TabletSYfb59c76a-9b6f-40ea-ac3a-58c3195c437721
900164lamotrigine 25 MG 24 HR Extended Release Oral TabletSYfb59c76a-9b6f-40ea-ac3a-58c3195c437721
1146690lamotrigine 250 MG 24 HR Extended Release Oral TabletSYfb59c76a-9b6f-40ea-ac3a-58c3195c437721
1098608lamotrigine 300 MG 24 HR Extended Release Oral TabletSYfb59c76a-9b6f-40ea-ac3a-58c3195c437721
850091lamotrigine 50 MG 24 HR Extended Release Oral TabletSYfb59c76a-9b6f-40ea-ac3a-58c3195c437721

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49884-604-0149884060401100 TABLET in 1 BOTTLE (49884-604-01) 100 tablet2013-01-180000-00-00NoNoCurrent
49884-604-0549884060405500 TABLET in 1 BOTTLE (49884-604-05) 500 tablet2013-01-180000-00-00NoNoCurrent
49884-604-114988406041130 TABLET in 1 BOTTLE (49884-604-11) 30 tablet2013-01-180000-00-00NoNoCurrent