LAMOTRIGINE

Product NDC
13668-047
11-digit product format
136680047
Labeler code
13668
Product ID
13668-047_e20d1c8d-dadf-4a54-8f0c-4ce62087f2e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LAMOTRIGINE
Dosage form
TABLET
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA078947
Marketing category
ANDA
Marketing start
2009-01-27
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

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

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
A078947-001LAMOTRIGINELAMOTRIGINE25MGTABLET / ORALAB2009-01-27
A078947-002LAMOTRIGINELAMOTRIGINE100MGTABLET / ORALAB2009-01-27
A078947-003LAMOTRIGINELAMOTRIGINE150MGTABLET / ORALAB2009-01-27
A078947-004LAMOTRIGINELAMOTRIGINE200MGTABLET / ORALAB2009-01-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078947-001AB
A078947-002AB
A078947-003AB
A078947-004AB

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 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078947-001LAMOTRIGINE25MGTABLET / ORALAB2009-01-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078947-002LAMOTRIGINE100MGTABLET / ORALAB2009-01-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078947-003LAMOTRIGINE150MGTABLET / ORALAB2009-01-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078947-004LAMOTRIGINE200MGTABLET / ORALAB2009-01-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078947-001LAMOTRIGINE25MGTABLET / ORALAB2009-01-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078947-002LAMOTRIGINE100MGTABLET / ORALAB2009-01-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078947-003LAMOTRIGINE150MGTABLET / ORALAB2009-01-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078947-004LAMOTRIGINE200MGTABLET / ORALAB2009-01-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A078947-001LAMOTRIGINE25MGTABLET / ORALAB2009-01-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078947-002LAMOTRIGINE100MGTABLET / ORALAB2009-01-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078947-003LAMOTRIGINE150MGTABLET / ORALAB2009-01-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078947-004LAMOTRIGINE200MGTABLET / ORALAB2009-01-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078947-001LAMOTRIGINE25MGTABLET / ORALAB2009-01-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078947-002LAMOTRIGINE100MGTABLET / ORALAB2009-01-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078947-003LAMOTRIGINE150MGTABLET / ORALAB2009-01-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078947-004LAMOTRIGINE200MGTABLET / ORALAB2009-01-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078947-001LAMOTRIGINE25MGTABLET / ORALAB2009-01-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078947-002LAMOTRIGINE100MGTABLET / ORALAB2009-01-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078947-003LAMOTRIGINE150MGTABLET / ORALAB2009-01-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078947-004LAMOTRIGINE200MGTABLET / ORALAB2009-01-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078947-001LAMOTRIGINE25MGTABLET / ORALAB2009-01-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078947-002LAMOTRIGINE100MGTABLET / ORALAB2009-01-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078947-003LAMOTRIGINE150MGTABLET / ORALAB2009-01-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078947-004LAMOTRIGINE200MGTABLET / ORALAB2009-01-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078947-001LAMOTRIGINE25MGTABLET / ORALAB2009-01-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078947-002LAMOTRIGINE100MGTABLET / ORALAB2009-01-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078947-003LAMOTRIGINE150MGTABLET / ORALAB2009-01-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078947-004LAMOTRIGINE200MGTABLET / ORALAB2009-01-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078947-001LAMOTRIGINE25MGTABLET / ORALAB2009-01-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078947-002LAMOTRIGINE100MGTABLET / ORALAB2009-01-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078947-003LAMOTRIGINE150MGTABLET / ORALAB2009-01-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078947-004LAMOTRIGINE200MGTABLET / ORALAB2009-01-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078947-001LAMOTRIGINE25MGTABLET / ORALAB2009-01-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078947-002LAMOTRIGINE100MGTABLET / ORALAB2009-01-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078947-003LAMOTRIGINE150MGTABLET / ORALAB2009-01-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078947-004LAMOTRIGINE200MGTABLET / ORALAB2009-01-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078947-001LAMOTRIGINE25MGTABLET / ORALAB2009-01-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A078947-002LAMOTRIGINE100MGTABLET / ORALAB2009-01-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A078947-003LAMOTRIGINE150MGTABLET / ORALAB2009-01-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A078947-004LAMOTRIGINE200MGTABLET / ORALAB2009-01-27d06236e962d9…

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 UTC2026-02A078947-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078947-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078947-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078947-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078947-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078947-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078947-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078947-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078947-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078947-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078947-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078947-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078947-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078947-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078947-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078947-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078947-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078947-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078947-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078947-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078947-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078947-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078947-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078947-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078947-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078947-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078947-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078947-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078947-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078947-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078947-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078947-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078947-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078947-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078947-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078947-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078947-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078947-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078947-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078947-004AB1d06236e962d9…

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 · 7 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198427Internal RxNorm lookup
198428Internal RxNorm lookup
198429Internal RxNorm lookup
282401Internal RxNorm lookup
751139Internal RxNorm lookup
751563Internal RxNorm lookup
753451Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3448839b-4933-4ef9-a80a-9e504d2c5696Available 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
13668-047-01LAMOTRIGINE100 in 1 BOTTLETABLET10026
13668-047-05LAMOTRIGINE500 in 1 BOTTLETABLET50026
13668-047-30LAMOTRIGINE30 in 1 BOTTLETABLET3026
13668-047-31LAMOTRIGINE2500 in 1 BOTTLETABLET250026
13668-047-60LAMOTRIGINE60 in 1 BOTTLETABLET6026
13668-047-74LAMOTRIGINE100 in 1 DOSE PACKTABLET10026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-047-01EA - Each13668-04717150ff2-d39f-45b9-9417-d9e7ddcd11ea12012-07-24
13668-047-05EA - Each13668-04715b872d1-0d7b-460f-ace6-21ae863aafb612012-07-24
13668-047-30EA - Each13668-047e1a9f409-b29c-4744-9acd-887751f9912412012-07-24
13668-047-74EA - Each13668-04776e8d7e5-0b1c-4251-8faf-803bb136334812012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-047LAMOTRIGINE TABLET LAMOTRIGINE (LAMOTRIGINE) KIT [TORRENT PHARMACEUTICALS LIMITED]23Current NDC, Legacy NDC, 6 package rows20240830_3448839b-4933-4ef9-a80a-9e504d2c5696.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LAMOTRIGINELAMOTRIGINEREMEDYREPACK INC.50d46278-636a-470e-afcc-d3c8bd844e462026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078947
application number: ANDA078947
LAMOTRIGINELAMOTRIGINEREMEDYREPACK INC.1d7c2d52-a78e-4508-8853-ba306cdeeaba2026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078947
application number: ANDA078947
LAMOTRIGINELAMOTRIGINETorrent Pharmaceuticals Limited3448839b-4933-4ef9-a80a-9e504d2c56962026-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078947
application number: ANDA078947
ndc (product): 13668-047
LAMOTRIGINELAMOTRIGINEPD-Rx Pharmaceuticals, Inc.f31e1854-6068-4e45-b1e5-6def862fc4662026-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078947
application number: ANDA078947
LAMOTRIGINELAMOTRIGINEPD-Rx Pharmaceuticals, Inc.c638ab70-05dd-4f8b-9a11-b33a75f8c5042026-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078947
application number: ANDA078947
LAMOTRIGINE KitLAMOTRIGINEOWP Pharmaceuticals, Inc.474fb321-575c-4b97-9dbe-080061652ee42026-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078947
application number: ANDA078947
SUBVENITELAMOTRIGINEOWP Pharmaceuticals, Inc.7ad18b68-ba16-4810-9c3e-27fa970454e82026-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078947
application number: ANDA078947
LAMOTRIGINELAMOTRIGINENorthwind Health Company, LLCf7587283-781b-e111-e053-6394a90ad4cc2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078947
application number: ANDA078947
LAMOTRIGINELAMOTRIGINENuCare Pharmaceuticals,Inc.1bbbe2a2-a9e8-8c13-e063-6394a90a96272024-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078947
application number: ANDA078947
LAMOTRIGINELAMOTRIGINEA-S Medication Solutions4e6cc1ad-55cd-4c7f-878c-fa6716e958972023-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078947
application number: ANDA078947

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198427lamoTRIgine 100 MG Oral TabletPSNf31e1854-6068-4e45-b1e5-6def862fc46627
198427lamotrigine 100 MG Oral TabletSCDf31e1854-6068-4e45-b1e5-6def862fc46627
753451{14 (lamotrigine 100 MG Oral Tablet) / 84 (lamotrigine 25 MG Oral Tablet) } PackGPCK3448839b-4933-4ef9-a80a-9e504d2c569626
751139{35 (lamotrigine 25 MG Oral Tablet) } PackGPCK3448839b-4933-4ef9-a80a-9e504d2c569626
751563{7 (lamotrigine 100 MG Oral Tablet) / 42 (lamotrigine 25 MG Oral Tablet) } PackGPCK3448839b-4933-4ef9-a80a-9e504d2c569626
198427lamoTRIgine 100 MG Oral TabletPSN3448839b-4933-4ef9-a80a-9e504d2c569626
198428lamoTRIgine 150 MG Oral TabletPSN3448839b-4933-4ef9-a80a-9e504d2c569626
198429lamoTRIgine 200 MG Oral TabletPSN3448839b-4933-4ef9-a80a-9e504d2c569626
751563lamoTRIgine 25 MG (42), 100 MG (7) Oral Tablet 49 Count PackPSN3448839b-4933-4ef9-a80a-9e504d2c569626
753451lamoTRIgine 25 MG (84), 100 MG (14) Oral Tablet 98 Count PackPSN3448839b-4933-4ef9-a80a-9e504d2c569626
282401lamoTRIgine 25 MG Oral TabletPSN3448839b-4933-4ef9-a80a-9e504d2c569626
751139lamoTRIgine 25 MG Oral Tablet 35 Count PackPSN3448839b-4933-4ef9-a80a-9e504d2c569626
198427lamotrigine 100 MG Oral TabletSCD3448839b-4933-4ef9-a80a-9e504d2c569626
198428lamotrigine 150 MG Oral TabletSCD3448839b-4933-4ef9-a80a-9e504d2c569626
198429lamotrigine 200 MG Oral TabletSCD3448839b-4933-4ef9-a80a-9e504d2c569626
282401lamotrigine 25 MG Oral TabletSCD3448839b-4933-4ef9-a80a-9e504d2c569626
751139lamotrigine Blue (For Patients Taking Valproate)SY3448839b-4933-4ef9-a80a-9e504d2c569626
753451lamotrigine Green (For Patients Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Rifampin and Not Taking Valproate)SY3448839b-4933-4ef9-a80a-9e504d2c569626
751563lamotrigine Orange (USP Starter Kit for Patients Not Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Valproate)SY3448839b-4933-4ef9-a80a-9e504d2c569626
198427lamoTRIgine 100 MG Oral TabletPSN1bbbe2a2-a9e8-8c13-e063-6394a90a96271
198427lamotrigine 100 MG Oral TabletSCD1bbbe2a2-a9e8-8c13-e063-6394a90a96271

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13668-047-0113668004701100 TABLET in 1 BOTTLE (13668-047-01) 100 tablet2009-01-270000-00-00NoNoCurrent
13668-047-0513668004705500 TABLET in 1 BOTTLE (13668-047-05) 500 tablet2009-01-270000-00-00NoNoCurrent
13668-047-301366800473030 TABLET in 1 BOTTLE (13668-047-30) 30 tablet2009-01-270000-00-00NoNoCurrent
13668-047-31136680047312500 TABLET in 1 BOTTLE (13668-047-31) 2500 tablet2009-01-270000-00-00NoNoCurrent
13668-047-601366800476060 TABLET in 1 BOTTLE (13668-047-60) 60 tablet2009-01-270000-00-00NoNoCurrent
13668-047-7413668004774100 TABLET in 1 DOSE PACK (13668-047-74) 100 tablet2009-01-270000-00-00NoNoCurrent