Lamotrigine

Product NDC
65084-179
Requested package NDC
65084-179-10
11-digit product format
650840179
Labeler code
65084
Product ID
65084-179_bb027b58-4819-5108-e053-2995a90a78a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
McKesson Corporation dba RX Pak
Application
ANDA077633
Marketing category
ANDA
Marketing start
2009-01-27
Marketing end
2021-07-31
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
0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage65084-17965084-179-10DDiscontinued 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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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…

FDA-Initiated Inactive NDC Indexing#

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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65084-179-106508401791010 BLISTER PACK in 1 BOX (65084-179-10) > 10 TABLET in 1 BLISTER PACK10 blister pack2019-09-052021-07-31NoNoCurrent