Lamotrigine

Product NDC
80425-0289
Requested package NDC
80425-0289-1
11-digit product format
804250289
Labeler code
80425
Product ID
80425-0289_2a9b9724-0258-e829-e063-6394a90a1c07
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA090170
Marketing category
ANDA
Marketing start
2023-03-24
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
2026-12-31
Current FDA listing
Yes

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
A090170-001LAMOTRIGINELAMOTRIGINE25MGTABLET / ORALAB2011-10-06
A090170-002LAMOTRIGINELAMOTRIGINE100MGTABLET / ORALAB2011-10-06
A090170-003LAMOTRIGINELAMOTRIGINE150MGTABLET / ORALAB2011-10-06
A090170-004LAMOTRIGINELAMOTRIGINE200MGTABLET / ORALAB2011-10-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090170-001AB
A090170-002AB
A090170-003AB
A090170-004AB

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 22:38:342026-08A090170-001LAMOTRIGINE25MGTABLET / ORALAB2011-10-0684e616aacf4f…
2026-09-14 22:38:342026-08A090170-002LAMOTRIGINE100MGTABLET / ORALAB2011-10-0684e616aacf4f…
2026-09-14 22:38:342026-08A090170-003LAMOTRIGINE150MGTABLET / ORALAB2011-10-0684e616aacf4f…
2026-09-14 22:38:342026-08A090170-004LAMOTRIGINE200MGTABLET / ORALAB2011-10-0684e616aacf4f…
2026-08-18 06:07:402026-07A090170-001LAMOTRIGINE25MGTABLET / ORALAB2011-10-06caaa826d4ba7…
2026-08-18 06:07:402026-07A090170-002LAMOTRIGINE100MGTABLET / ORALAB2011-10-06caaa826d4ba7…
2026-08-18 06:07:402026-07A090170-003LAMOTRIGINE150MGTABLET / ORALAB2011-10-06caaa826d4ba7…
2026-08-18 06:07:402026-07A090170-004LAMOTRIGINE200MGTABLET / ORALAB2011-10-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090170-001LAMOTRIGINE25MGTABLET / ORALAB2011-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090170-002LAMOTRIGINE100MGTABLET / ORALAB2011-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090170-003LAMOTRIGINE150MGTABLET / ORALAB2011-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090170-004LAMOTRIGINE200MGTABLET / ORALAB2011-10-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090170-001LAMOTRIGINE25MGTABLET / ORALAB2011-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090170-002LAMOTRIGINE100MGTABLET / ORALAB2011-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090170-003LAMOTRIGINE150MGTABLET / ORALAB2011-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090170-004LAMOTRIGINE200MGTABLET / ORALAB2011-10-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A090170-001LAMOTRIGINE25MGTABLET / ORALAB2011-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090170-002LAMOTRIGINE100MGTABLET / ORALAB2011-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090170-003LAMOTRIGINE150MGTABLET / ORALAB2011-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090170-004LAMOTRIGINE200MGTABLET / ORALAB2011-10-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090170-001LAMOTRIGINE25MGTABLET / ORALAB2011-10-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090170-002LAMOTRIGINE100MGTABLET / ORALAB2011-10-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090170-003LAMOTRIGINE150MGTABLET / ORALAB2011-10-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090170-004LAMOTRIGINE200MGTABLET / ORALAB2011-10-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090170-001LAMOTRIGINE25MGTABLET / ORALAB2011-10-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090170-002LAMOTRIGINE100MGTABLET / ORALAB2011-10-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090170-003LAMOTRIGINE150MGTABLET / ORALAB2011-10-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090170-004LAMOTRIGINE200MGTABLET / ORALAB2011-10-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090170-001LAMOTRIGINE25MGTABLET / ORALAB2011-10-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090170-002LAMOTRIGINE100MGTABLET / ORALAB2011-10-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090170-003LAMOTRIGINE150MGTABLET / ORALAB2011-10-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090170-004LAMOTRIGINE200MGTABLET / ORALAB2011-10-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090170-001LAMOTRIGINE25MGTABLET / ORALAB2011-10-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090170-002LAMOTRIGINE100MGTABLET / ORALAB2011-10-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090170-003LAMOTRIGINE150MGTABLET / ORALAB2011-10-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090170-004LAMOTRIGINE200MGTABLET / ORALAB2011-10-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090170-001LAMOTRIGINE25MGTABLET / ORALAB2011-10-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090170-002LAMOTRIGINE100MGTABLET / ORALAB2011-10-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090170-003LAMOTRIGINE150MGTABLET / ORALAB2011-10-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090170-004LAMOTRIGINE200MGTABLET / ORALAB2011-10-065bbf6a4d5a75…

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 22:38:342026-08A090170-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A090170-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A090170-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A090170-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A090170-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090170-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090170-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090170-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090170-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090170-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090170-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090170-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090170-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090170-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090170-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090170-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090170-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090170-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090170-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090170-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090170-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090170-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090170-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090170-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090170-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090170-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090170-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090170-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090170-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090170-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090170-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090170-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090170-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090170-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090170-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090170-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090170-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090170-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090170-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090170-004AB15bbf6a4d5a75…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Lamotrigine
Listing expiration
2026-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
f7a86237-ece4-7cc4-e053-6294a90a1308Available 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
80425-0289-1Lamotrigine30 in 1 BOTTLETABLET302
80425-0289-2Lamotrigine60 in 1 BOTTLETABLET602
80425-0289-3Lamotrigine90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0289-1EA - Each80425-0289902fd383-e045-4a04-90d7-c3bbdb9daed712023-04-07
80425-0289-2EA - Each80425-0289ad005172-4479-47ce-9e8b-01da723d13c112023-04-07
80425-0289-3EA - Each80425-0289cf9f90dc-57c1-4142-8119-8d5139a8e74412023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0289LAMOTRIGINE TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 3 package rows20250102_f7a86237-ece4-7cc4-e053-6294a90a1308.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 2 · 24 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LamotrigineLAMOTRIGINEA-S Medication Solutions6139a858-700c-4eb9-9f84-99d280bde3262026-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090170
application number: ANDA090170
LamotrigineLAMOTRIGINEREMEDYREPACK INC.d1691a60-ff0a-4755-b445-1d78309d5af02026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090170
application number: ANDA090170
LamotrigineLAMOTRIGINEREMEDYREPACK INC.346f8af3-b850-48e4-bd6e-82ecafca86d22026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090170
application number: ANDA090170
LamotrigineLAMOTRIGINEREMEDYREPACK INC.f5761818-4eaf-4335-a77a-9cd703278ded2026-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090170
application number: ANDA090170
LamotrigineLAMOTRIGINEREMEDYREPACK INC.1b5646a9-4724-44b8-8cd0-9c14f5e87f862026-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090170
application number: ANDA090170
LamotrigineLAMOTRIGINECoupler LLC55f41c7e-03a6-b84c-e063-6294a90a7d822026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090170
application number: ANDA090170
LamotrigineLAMOTRIGINEREMEDYREPACK INC.3ed4590d-71e3-4208-b6c0-98330acc7b852026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090170
application number: ANDA090170
LamotrigineLAMOTRIGINECoupler LLC545fcc0e-1e2b-bdcb-e063-6294a90a4ac72026-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090170
application number: ANDA090170
LamotrigineLAMOTRIGINEBryant Ranch Prepackb1601109-5c17-4482-9257-1e0be7546e8f2026-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090170
application number: ANDA090170
LamotrigineLAMOTRIGINECoupler LLC52b8be5c-ef88-dfa7-e063-6394a90a05002026-05-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090170
application number: ANDA090170
LamotrigineLAMOTRIGINEUnichem Pharmaceuticals (USA), Inc.4b72ea7a-a0b0-4980-84ad-84f64e2e63682026-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090170
application number: ANDA090170
LamotrigineLAMOTRIGINEPreferred Pharmaceuticals, Inc.16323699-9bf8-43c7-b3aa-5891563778722026-05-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090170
application number: ANDA090170
LamotrigineLAMOTRIGINEPreferred Pharmaceuticals Inc.09a0d30d-9b8f-4c76-8cdb-8492386b22542026-05-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090170
application number: ANDA090170
LamotrigineLAMOTRIGINENorthwind Health Company, LLCdb5f7ee5-9bd9-1819-e053-2a95a90a91df2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090170
application number: ANDA090170
LamotrigineLAMOTRIGINEA-S Medication Solutions84277e2c-370c-4510-92bc-ef33a4a0f5082025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090170
application number: ANDA090170
LamotrigineLAMOTRIGINEBryant Ranch Prepack8e1e4fa8-881c-4618-88f6-018ab15db44d2025-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090170
application number: ANDA090170
LamotrigineLAMOTRIGINEBryant Ranch Prepack812bc0d8-bb31-4fb1-9f4a-f8c17cbc769c2025-09-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090170
application number: ANDA090170
LamotrigineLAMOTRIGINEBryant Ranch Prepack53774022-ea0c-42a9-a720-dc755c77b8512025-09-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090170
application number: ANDA090170
LAMOTRIGINELAMOTRIGINEDIRECT RXa835b697-2beb-1ba8-e053-2995a90a470c2025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090170
application number: ANDA090170
LamotrigineLAMOTRIGINEAdvanced Rx Pharmacy of Tennessee, LLCf7a86237-ece4-7cc4-e053-6294a90a13082024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090170
application number: ANDA090170
ndc (package): 80425-0289-1
ndc (product): 80425-0289
ndc11 (package): 80425028901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
282401lamoTRIgine 25 MG Oral TabletPSNf7a86237-ece4-7cc4-e053-6294a90a13082
282401lamotrigine 25 MG Oral TabletSCDf7a86237-ece4-7cc4-e053-6294a90a13082

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0289-18042502890130 TABLET in 1 BOTTLE (80425-0289-1) 30 tablet2023-03-24NoNoCurrent