Lamotrigine

Product NDC
16714-194
11-digit product format
167140194
Labeler code
16714
Product ID
16714-194_f6d6f71c-c94d-4bde-ac57-850998dad74f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
Northstar Rx LLC.
Application
ANDA077633
Marketing category
ANDA
Marketing start
2021-11-17
Substance
LAMOTRIGINE
Active strength
25 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

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
LAMOTRIGINE25 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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198427Internal RxNorm lookup
198428Internal RxNorm lookup
198429Internal RxNorm lookup
282401Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
aabc64fe-1f17-4140-81f2-7d4506db6c8bAvailable 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
16714-194-01Lamotrigine100 in 1 BOTTLETABLET1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-194-01EA - Each16714-194f7508dfe-ca72-4c61-a5e8-b5321776924212022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-194LAMOTRIGINE TABLET [NORTHSTAR RX LLC.]4Current NDC, Legacy NDC, 1 package rows20230406_aabc64fe-1f17-4140-81f2-7d4506db6c8b.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
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
ndc (product): 16714-194
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 TabletPSNaabc64fe-1f17-4140-81f2-7d4506db6c8b6
198428lamoTRIgine 150 MG Oral TabletPSNaabc64fe-1f17-4140-81f2-7d4506db6c8b6
198429lamoTRIgine 200 MG Oral TabletPSNaabc64fe-1f17-4140-81f2-7d4506db6c8b6
282401lamoTRIgine 25 MG Oral TabletPSNaabc64fe-1f17-4140-81f2-7d4506db6c8b6
198427lamotrigine 100 MG Oral TabletSCDaabc64fe-1f17-4140-81f2-7d4506db6c8b6
198428lamotrigine 150 MG Oral TabletSCDaabc64fe-1f17-4140-81f2-7d4506db6c8b6
198429lamotrigine 200 MG Oral TabletSCDaabc64fe-1f17-4140-81f2-7d4506db6c8b6
282401lamotrigine 25 MG Oral TabletSCDaabc64fe-1f17-4140-81f2-7d4506db6c8b6
282401lamoTRIgine 25 MG Oral TabletPSNf8ff063a-e962-6fbb-e053-6294a90afa081
282401lamotrigine 25 MG Oral TabletSCDf8ff063a-e962-6fbb-e053-6294a90afa081

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-194-0116714019401100 TABLET in 1 BOTTLE (16714-194-01) 100 tablet2021-11-170000-00-00NoNoCurrent