Lamotrigine

Product NDC
70771-1519
11-digit product format
707711519
Labeler code
70771
Product ID
70771-1519_c2007dd5-98b7-47e2-8354-7ce432174a48
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotirigine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA207763
Marketing category
ANDA
Marketing start
2020-05-14
Substance
LAMOTRIGINE
Active strength
300 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 42.

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
A207763-001LAMOTRIGINELAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORALAB2020-04-01
A207763-002LAMOTRIGINELAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORALAB2020-04-01
A207763-003LAMOTRIGINELAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2020-04-01
A207763-004LAMOTRIGINELAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORALAB2020-04-01
A207763-005LAMOTRIGINELAMOTRIGINE250MGTABLET, EXTENDED RELEASE / ORALAB2020-04-01
A207763-006LAMOTRIGINELAMOTRIGINE300MGTABLET, EXTENDED RELEASE / ORALAB2020-04-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
A207763-001AB
A207763-002AB
A207763-003AB
A207763-004AB
A207763-005AB
A207763-006AB

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 6 · 228 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A207763-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORALAB2020-04-01caaa826d4ba7…
2026-08-18 06:07:402026-07A207763-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORALAB2020-04-01caaa826d4ba7…
2026-08-18 06:07:402026-07A207763-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2020-04-01caaa826d4ba7…
2026-08-18 06:07:402026-07A207763-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORALAB2020-04-01caaa826d4ba7…
2026-08-18 06:07:402026-07A207763-005LAMOTRIGINE250MGTABLET, EXTENDED RELEASE / ORALAB2020-04-01caaa826d4ba7…
2026-08-18 06:07:402026-07A207763-006LAMOTRIGINE300MGTABLET, EXTENDED RELEASE / ORALAB2020-04-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207763-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORALAB2020-04-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207763-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORALAB2020-04-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207763-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2020-04-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207763-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORALAB2020-04-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207763-005LAMOTRIGINE250MGTABLET, EXTENDED RELEASE / ORALAB2020-04-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207763-006LAMOTRIGINE300MGTABLET, EXTENDED RELEASE / ORALAB2020-04-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207763-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORALAB2020-04-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207763-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORALAB2020-04-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207763-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2020-04-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207763-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORALAB2020-04-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207763-005LAMOTRIGINE250MGTABLET, EXTENDED RELEASE / ORALAB2020-04-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207763-006LAMOTRIGINE300MGTABLET, EXTENDED RELEASE / ORALAB2020-04-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207763-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORALAB2020-04-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207763-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORALAB2020-04-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207763-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2020-04-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207763-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORALAB2020-04-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207763-005LAMOTRIGINE250MGTABLET, EXTENDED RELEASE / ORALAB2020-04-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207763-006LAMOTRIGINE300MGTABLET, EXTENDED RELEASE / ORALAB2020-04-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207763-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORALAB2020-04-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207763-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORALAB2020-04-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207763-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2020-04-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207763-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORALAB2020-04-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207763-005LAMOTRIGINE250MGTABLET, EXTENDED RELEASE / ORALAB2020-04-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207763-006LAMOTRIGINE300MGTABLET, EXTENDED RELEASE / ORALAB2020-04-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207763-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORALAB2020-04-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207763-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORALAB2020-04-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207763-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2020-04-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207763-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORALAB2020-04-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207763-005LAMOTRIGINE250MGTABLET, EXTENDED RELEASE / ORALAB2020-04-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207763-006LAMOTRIGINE300MGTABLET, EXTENDED RELEASE / ORALAB2020-04-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207763-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORALAB2020-04-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207763-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORALAB2020-04-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207763-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2020-04-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207763-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORALAB2020-04-0103ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 228 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A207763-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207763-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207763-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207763-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207763-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207763-006AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207763-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207763-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207763-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207763-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207763-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207763-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207763-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207763-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207763-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207763-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207763-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207763-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207763-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207763-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207763-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207763-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207763-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207763-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207763-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207763-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207763-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207763-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207763-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207763-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207763-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207763-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207763-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207763-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207763-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207763-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207763-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207763-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207763-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207763-004AB103ed91905a0d…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LAMOTRIGINE300 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 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
850087Internal RxNorm lookup
850091Internal RxNorm lookup
900156Internal RxNorm lookup
900164Internal RxNorm lookup
1098608Internal RxNorm lookup
1146690Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ecb7a528-699f-4e51-9887-dee60456da2fAvailable 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
70771-1519-2Lamotrigine10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE105
70771-1519-3Lamotrigine30 in 1 BOTTLETABLET, EXTENDED RELEASE305
70771-1519-4Lamotrigine10 in 1 CARTONTABLET, EXTENDED RELEASE105
70771-1519-5Lamotrigine500 in 1 BOTTLETABLET, EXTENDED RELEASE5005
70771-1519-9Lamotrigine90 in 1 BOTTLETABLET, EXTENDED RELEASE905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1519LAMOTRIGINE (LAMOTIRIGINE) TABLET, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED]5Current NDC, Legacy NDC, 5 package rows20241204_ecb7a528-699f-4e51-9887-dee60456da2f.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LamotrigineLAMOTRIGINEREMEDYREPACK INC.fa679e97-3b3d-4bf2-8de7-da3a89e38b372026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207763
application number: ANDA207763
LamotrigineLAMOTRIGINEZydus Pharmaceuticals USA Inc.eb436371-d188-4803-a864-07b90c357e572025-11-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207763
application number: ANDA207763
Lamotrigine ERLAMOTRIGINE ERDirect_Rxfaccacb7-65f1-cb00-e053-6394a90a9fcb2025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207763
application number: ANDA207763
LamotrigineLAMOTIRIGINEZydus Lifesciences Limitedecb7a528-699f-4e51-9887-dee60456da2f2024-11-30Exact identifier
application applno (ANDA): 207763
application number: ANDA207763
ndc (product): 70771-1519

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
850087lamoTRIgine 100 MG 24HR Extended Release Oral TabletPSNecb7a528-699f-4e51-9887-dee60456da2f5
900156lamoTRIgine 200 MG 24HR Extended Release Oral TabletPSNecb7a528-699f-4e51-9887-dee60456da2f5
900164lamoTRIgine 25 MG 24HR Extended Release Oral TabletPSNecb7a528-699f-4e51-9887-dee60456da2f5
1146690lamoTRIgine 250 MG 24HR Extended Release Oral TabletPSNecb7a528-699f-4e51-9887-dee60456da2f5
1098608lamoTRIgine 300 MG 24HR Extended Release Oral TabletPSNecb7a528-699f-4e51-9887-dee60456da2f5
850091lamoTRIgine 50 MG 24HR Extended Release Oral TabletPSNecb7a528-699f-4e51-9887-dee60456da2f5
85008724 HR lamotrigine 100 MG Extended Release Oral TabletSCDecb7a528-699f-4e51-9887-dee60456da2f5
90015624 HR lamotrigine 200 MG Extended Release Oral TabletSCDecb7a528-699f-4e51-9887-dee60456da2f5
90016424 HR lamotrigine 25 MG Extended Release Oral TabletSCDecb7a528-699f-4e51-9887-dee60456da2f5
114669024 HR lamotrigine 250 MG Extended Release Oral TabletSCDecb7a528-699f-4e51-9887-dee60456da2f5
109860824 HR lamotrigine 300 MG Extended Release Oral TabletSCDecb7a528-699f-4e51-9887-dee60456da2f5
85009124 HR lamotrigine 50 MG Extended Release Oral TabletSCDecb7a528-699f-4e51-9887-dee60456da2f5
850087lamotrigine 100 MG 24 HR Extended Release Oral TabletSYecb7a528-699f-4e51-9887-dee60456da2f5
900156lamotrigine 200 MG 24 HR Extended Release Oral TabletSYecb7a528-699f-4e51-9887-dee60456da2f5
900164lamotrigine 25 MG 24 HR Extended Release Oral TabletSYecb7a528-699f-4e51-9887-dee60456da2f5
1146690lamotrigine 250 MG 24 HR Extended Release Oral TabletSYecb7a528-699f-4e51-9887-dee60456da2f5
1098608lamotrigine 300 MG 24 HR Extended Release Oral TabletSYecb7a528-699f-4e51-9887-dee60456da2f5
850091lamotrigine 50 MG 24 HR Extended Release Oral TabletSYecb7a528-699f-4e51-9887-dee60456da2f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1519-27077115190210 in 1 BLISTER PACKHistorical
70771-1519-37077115190330 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1519-3) 2020-05-140000-00-00NoNoCurrent
70771-1519-47077115190410 BLISTER PACK in 1 CARTON (70771-1519-4) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70771-1519-2) 10 blister pack2020-05-140000-00-00NoNoCurrent
70771-1519-570771151905500 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1519-5) 2020-05-140000-00-00NoNoCurrent
70771-1519-97077115190990 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1519-9) 2020-05-140000-00-00NoNoCurrent