FDA.reportPublic FDA data

Lamotrigine

Product NDC
70518-2503
Requested package NDC
70518-2503-0
11-digit product format
705182503
Labeler code
70518
Product ID
70518-2503_c9c24d97-58c8-3301-e053-2a95a90a8aa4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA079132
Marketing category
ANDA
Marketing start
2019-12-23
Marketing end
0000-00-00
Substance
LAMOTRIGINE
Active strength
200 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
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-250370518-2503-0DDiscontinued by firm2026-07-31

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
A079132-001LAMOTRIGINELAMOTRIGINE25MGTABLET / ORALAB2009-01-27
A079132-002LAMOTRIGINELAMOTRIGINE100MGTABLET / ORALAB2009-01-27
A079132-003LAMOTRIGINELAMOTRIGINE150MGTABLET / ORALAB2009-01-27
A079132-004LAMOTRIGINELAMOTRIGINE200MGTABLET / 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
A079132-001AB
A079132-002AB
A079132-003AB
A079132-004AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A079132-001LAMOTRIGINE25MGTABLET / ORALAB2009-01-27a50c72e98297…
2026-08-01 22:54:322026-06A079132-002LAMOTRIGINE100MGTABLET / ORALAB2009-01-27a50c72e98297…
2026-08-01 22:54:322026-06A079132-003LAMOTRIGINE150MGTABLET / ORALAB2009-01-27a50c72e98297…
2026-08-01 22:54:322026-06A079132-004LAMOTRIGINE200MGTABLET / ORALAB2009-01-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A079132-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A079132-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A079132-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A079132-004AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LamotrigineLAMOTRIGINEAvKAREfcdb94a8-33be-6375-98ef-6933999d157f2026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079132
application number: ANDA079132
LamotrigineLAMOTRIGINEBryant Ranch Prepackd33c4293-347c-49a1-9d98-f291c3dab6da2025-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079132
application number: ANDA079132
LamotrigineLAMOTRIGINEJubilant Cadista Pharmacuticals Inc.0b0f0209-edbd-46f3-9bed-762cbea0d7372025-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079132
application number: ANDA079132

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2503-02023-03-10C16284748780-1f386c64a-041d-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use LAMOTRIGINE TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE TABLETS. LAMOTRIGINE tablets, for oral use Initial U.S. Approval: 1994
70518-2503-12023-03-10C16284748780-1f386c64a-041d-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use LAMOTRIGINE TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE TABLETS. LAMOTRIGINE tablets, for oral use Initial U.S. Approval: 1994
70518-2503-02023-01-30C16284748780-1f386c64a-041d-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use LAMOTRIGINE TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE TABLETS. LAMOTRIGINE tablets, for oral use Initial U.S. Approval: 1994
70518-2503-12023-01-30C16284748780-1f386c64a-041d-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use LAMOTRIGINE TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE TABLETS. LAMOTRIGINE tablets, for oral use Initial U.S. Approval: 1994

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2503-07051825030030 TABLET in 1 BLISTER PACK (70518-2503-0) 30 tablet2019-12-230000-00-00NoNoCurrent