Home NDC 70518-3602-0 Lamotrigine
Product NDC 70518-3602
Requested package NDC 70518-3602-0
11-digit product format 705183602
Labeler code 70518
Product ID 70518-3602_f214021b-d5be-a545-e053-2a95a90ae2c7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lamotrigine
Dosage form TABLET
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA078625
Marketing category ANDA
Marketing start 2023-01-04
Marketing end 0000-00-00
Substance LAMOTRIGINE
Active strength 200 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 2024-12-31
Current FDA listing Historical FDA.report record 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078625-001 LAMOTRIGINE LAMOTRIGINE 25MG TABLET / ORAL AB 2009-01-27 A078625-002 LAMOTRIGINE LAMOTRIGINE 100MG TABLET / ORAL AB 2009-01-27 A078625-003 LAMOTRIGINE LAMOTRIGINE 150MG TABLET / ORAL AB 2009-01-27 A078625-004 LAMOTRIGINE LAMOTRIGINE 200MG TABLET / ORAL AB 2009-01-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A078625-001 LAMOTRIGINE 25MG TABLET / ORAL AB 2009-01-27 a50c72e98297…2026-08-01 22:54:32 2026-06 A078625-002 LAMOTRIGINE 100MG TABLET / ORAL AB 2009-01-27 a50c72e98297…2026-08-01 22:54:32 2026-06 A078625-003 LAMOTRIGINE 150MG TABLET / ORAL AB 2009-01-27 a50c72e98297…2026-08-01 22:54:32 2026-06 A078625-004 LAMOTRIGINE 200MG TABLET / ORAL AB 2009-01-27 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lamotrigine LAMOTRIGINE Advagen Pharma Limited 4ca9d713-ab63-48bf-9386-29301a842e60 2025-11-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078625 application number: ANDA078625
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-3602 LAMOTRIGINE TABLET [REMEDYREPACK INC.] 5 Legacy NDC 20240412_fa0c0106-de02-48e9-a8c7-2953033dd8e5.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70518-3602-0 70518360200 30 TABLET in 1 BLISTER PACK (70518-3602-0) 30 tablet 2023-01-04 0000-00-00 No No Current