Lamotrigine

Product NDC
70518-2563
11-digit product format
705182563
Labeler code
70518
Product ID
70518-2563_4a67dac3-1748-45bd-e063-6294a90ad9d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077633
Marketing category
ANDA
Marketing start
2020-02-04
Substance
LAMOTRIGINE
Active strength
100 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
2027-12-31
Current FDA listing
Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-256370518-2563-1DDiscontinued by firm2026-08-03

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 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-256370518-2563-1DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A077633-001LAMOTRIGINELAMOTRIGINE25MGTABLET / ORALAB2009-01-27
A077633-002LAMOTRIGINELAMOTRIGINE50MGTABLET / ORAL2009-01-27
A077633-003LAMOTRIGINELAMOTRIGINE100MGTABLET / ORALAB2009-01-27
A077633-004LAMOTRIGINELAMOTRIGINE150MGTABLET / ORALAB2009-01-27
A077633-005LAMOTRIGINELAMOTRIGINE200MGTABLET / ORALAB2009-01-27
A077633-006LAMOTRIGINELAMOTRIGINE250MGTABLET / ORAL2009-01-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077633-001AB
A077633-003AB
A077633-004AB
A077633-005AB

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 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077633-001LAMOTRIGINE25MGTABLET / ORALAB2009-01-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077633-002LAMOTRIGINE50MGTABLET / ORAL2009-01-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077633-003LAMOTRIGINE100MGTABLET / ORALAB2009-01-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077633-004LAMOTRIGINE150MGTABLET / ORALAB2009-01-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077633-005LAMOTRIGINE200MGTABLET / ORALAB2009-01-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077633-006LAMOTRIGINE250MGTABLET / ORAL2009-01-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077633-001LAMOTRIGINE25MGTABLET / ORALAB2009-01-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077633-002LAMOTRIGINE50MGTABLET / ORAL2009-01-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077633-003LAMOTRIGINE100MGTABLET / ORALAB2009-01-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077633-004LAMOTRIGINE150MGTABLET / ORALAB2009-01-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077633-005LAMOTRIGINE200MGTABLET / ORALAB2009-01-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077633-006LAMOTRIGINE250MGTABLET / ORAL2009-01-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A077633-001LAMOTRIGINE25MGTABLET / ORALAB2009-01-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077633-002LAMOTRIGINE50MGTABLET / ORAL2009-01-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077633-003LAMOTRIGINE100MGTABLET / ORALAB2009-01-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077633-004LAMOTRIGINE150MGTABLET / ORALAB2009-01-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077633-005LAMOTRIGINE200MGTABLET / ORALAB2009-01-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077633-006LAMOTRIGINE250MGTABLET / ORAL2009-01-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077633-001LAMOTRIGINE25MGTABLET / ORALAB2009-01-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077633-002LAMOTRIGINE50MGTABLET / ORAL2009-01-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077633-003LAMOTRIGINE100MGTABLET / ORALAB2009-01-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077633-004LAMOTRIGINE150MGTABLET / ORALAB2009-01-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077633-005LAMOTRIGINE200MGTABLET / ORALAB2009-01-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077633-006LAMOTRIGINE250MGTABLET / ORAL2009-01-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077633-001LAMOTRIGINE25MGTABLET / ORALAB2009-01-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077633-002LAMOTRIGINE50MGTABLET / ORAL2009-01-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077633-003LAMOTRIGINE100MGTABLET / ORALAB2009-01-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077633-004LAMOTRIGINE150MGTABLET / ORALAB2009-01-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077633-005LAMOTRIGINE200MGTABLET / ORALAB2009-01-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077633-006LAMOTRIGINE250MGTABLET / ORAL2009-01-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077633-001LAMOTRIGINE25MGTABLET / ORALAB2009-01-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077633-002LAMOTRIGINE50MGTABLET / ORAL2009-01-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077633-003LAMOTRIGINE100MGTABLET / ORALAB2009-01-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077633-004LAMOTRIGINE150MGTABLET / ORALAB2009-01-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077633-005LAMOTRIGINE200MGTABLET / ORALAB2009-01-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077633-006LAMOTRIGINE250MGTABLET / ORAL2009-01-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077633-001LAMOTRIGINE25MGTABLET / ORALAB2009-01-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077633-002LAMOTRIGINE50MGTABLET / ORAL2009-01-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077633-003LAMOTRIGINE100MGTABLET / ORALAB2009-01-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077633-004LAMOTRIGINE150MGTABLET / ORALAB2009-01-272680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077633-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077633-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077633-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077633-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077633-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077633-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077633-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077633-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077633-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077633-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077633-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077633-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077633-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077633-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077633-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077633-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077633-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077633-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077633-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077633-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077633-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077633-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077633-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077633-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077633-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077633-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077633-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077633-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077633-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077633-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077633-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077633-005AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077633-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077633-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077633-004AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077633-005AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077633-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077633-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077633-004AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077633-005AB1d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
Lamotrigine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LAMOTRIGINE100 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198427Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
15d801a0-f0a5-40c1-bc88-d5ba9a02c696Available 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
e29d8e8b-4bc8-ebaf-f18e-e35287b19d6aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2563-0Lamotrigine30 in 1 BLISTER PACKTABLET3014
70518-2563-1Lamotrigine30 in 1 BOTTLE, PLASTICTABLET3014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2563LAMOTRIGINE TABLET [REMEDYREPACK INC.]10Current NDC, Legacy NDC, 2 package rows20250423_15d801a0-f0a5-40c1-bc88-d5ba9a02c696.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 · 18 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LamotrigineLAMOTRIGINEAmerican Health Packaging35aa48a2-2ce6-4a6e-bf5a-1bc6111d12342026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077633
application number: ANDA077633
LamotrigineLAMOTRIGINEREMEDYREPACK INC.15d801a0-f0a5-40c1-bc88-d5ba9a02c6962026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077633
application number: ANDA077633
ndc (product): 70518-2563
LamotrigineLAMOTRIGINECardinal Health 107, LLC20e156df-a2b6-4710-b526-0419cd17dd332026-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077633
application number: ANDA077633
LamotrigineLAMOTRIGINEMajor Pharmaceuticals12e0be85-0961-4fe0-b973-83251ecf0f652026-05-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077633
application number: ANDA077633
LamotrigineLAMOTRIGINEAmerican Health Packaging6034a8b8-9e80-43ca-b84f-ea82f788268c2026-03-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077633
application number: ANDA077633
LamotrigineLAMOTRIGINEPreferred Pharmaceuticals Inc.634dbe6c-4874-4d54-aa25-be02d3341f162026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077633
application number: ANDA077633
LamotrigineLAMOTRIGINEQuallent Pharmaceuticals Health LLC7977c87f-b459-486a-9edc-0a2071c46f4c2026-01-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077633
application number: ANDA077633
LamotrigineLAMOTRIGINENorthwind Health Company, LLC03fd8413-df56-50ab-e063-6394a90a69502026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077633
application number: ANDA077633
LamotrigineLAMOTRIGINENorthstar Rx LLC.aabc64fe-1f17-4140-81f2-7d4506db6c8b2025-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077633
application number: ANDA077633
LamotrigineLAMOTRIGINECardinal Health 107, LLCbeb24a4f-ab0b-435a-b60b-2b8d565ecd752025-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077633
application number: ANDA077633
LamotrigineLAMOTRIGINEZydus Pharmaceuticals USA Inc.e849033b-a3bc-408e-88de-7cd1d26609492025-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077633
application number: ANDA077633
LamotrigineLAMOTRIGINEZydus Lifesciences Limited0f2f7421-56d4-45d0-9d2d-dc1edaede0392025-10-04Exact identifier
application applno (ANDA): 077633
application number: ANDA077633
LamotrigineLAMOTRIGINEBryant Ranch Prepack2cf33586-e48a-4b4e-b14b-33de2be63c1d2025-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077633
application number: ANDA077633
LamotrigineLAMOTRIGINEBryant Ranch Prepack4bbc140c-6092-416d-865d-49b89c5ecdd02025-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077633
application number: ANDA077633
LamotrigineLAMOTRIGINEBryant Ranch Prepackcf03f130-067f-401c-8501-0d78a989a3192025-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077633
application number: ANDA077633
LamotrigineLAMOTRIGINENuCare Pharmaceuticals,Inc.065e97c9-3c5f-16e6-e063-6294a90a13fc2025-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077633
application number: ANDA077633
LamotrigineLAMOTRIGINENCS HealthCare of KY, LLC dba Vangard Labse243e803-e95f-47a6-a6da-5fed657f44622024-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077633
application number: ANDA077633
LamotrigineLAMOTRIGINEA-S Medication Solutions5a9575bb-230e-46ae-b58e-41554bad45eb2023-11-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077633
application number: ANDA077633

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198427lamoTRIgine 100 MG Oral TabletPSN15d801a0-f0a5-40c1-bc88-d5ba9a02c69614
198427lamotrigine 100 MG Oral TabletSCD15d801a0-f0a5-40c1-bc88-d5ba9a02c69614

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2563-07051825630030 TABLET in 1 BLISTER PACK (70518-2563-0) 30 tablet2020-02-040000-00-00NoNoCurrent
70518-2563-17051825630130 TABLET in 1 BOTTLE, PLASTIC (70518-2563-1) 30 tablet2022-11-100000-00-00NoNoCurrent