Home NDC 55289-410 LAMICTAL
Product NDC 55289-410
11-digit product format 552890410
Labeler code 55289
Product ID 55289-410_e235bc7d-4d25-240e-e053-2a95a90ad235
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lamotrigine
Dosage form TABLET
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application NDA020241
Marketing category NDA
Marketing start 1995-01-17
Marketing end 0000-00-00
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 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 55289-410-30 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 55289-410-30 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 55289-410-30 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 55289-410-30 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 55289-410-30 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 55289-410-30 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 55289-410-30 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 55289-410-30 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 55289-410-30 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 55289-410-30 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 55289-410-30 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 55289-410-30 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020241-001 LAMICTAL LAMOTRIGINE 100MG TABLET / ORAL AB RLD 1994-12-27 N020241-002 LAMICTAL LAMOTRIGINE 150MG TABLET / ORAL AB RLD 1994-12-27 N020241-003 LAMICTAL LAMOTRIGINE 200MG TABLET / ORAL AB RLD 1994-12-27 N020241-004 LAMICTAL LAMOTRIGINE 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1994-12-27 N020241-005 LAMICTAL LAMOTRIGINE 25MG TABLET / ORAL AB RLD 1994-12-27 N020241-006 LAMICTAL LAMOTRIGINE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1994-12-27
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.
Product history page 1 of 7 · 246 observed 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 2026-02-19 14:30 UTC 2026-02 N020241-001 LAMICTAL 100MG TABLET / ORAL AB RLD 1994-12-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020241-002 LAMICTAL 150MG TABLET / ORAL AB RLD 1994-12-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020241-003 LAMICTAL 200MG TABLET / ORAL AB RLD 1994-12-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020241-004 LAMICTAL 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1994-12-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020241-005 LAMICTAL 25MG TABLET / ORAL AB RLD, RS 1994-12-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020241-006 LAMICTAL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1994-12-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020241-001 LAMICTAL 100MG TABLET / ORAL AB RLD 1994-12-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020241-002 LAMICTAL 150MG TABLET / ORAL AB RLD 1994-12-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020241-003 LAMICTAL 200MG TABLET / ORAL AB RLD 1994-12-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020241-004 LAMICTAL 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1994-12-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020241-005 LAMICTAL 25MG TABLET / ORAL AB RLD, RS 1994-12-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020241-006 LAMICTAL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1994-12-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020241-001 LAMICTAL 100MG TABLET / ORAL AB RLD 1994-12-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020241-002 LAMICTAL 150MG TABLET / ORAL AB RLD 1994-12-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020241-003 LAMICTAL 200MG TABLET / ORAL AB RLD 1994-12-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020241-004 LAMICTAL 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1994-12-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020241-005 LAMICTAL 25MG TABLET / ORAL AB RLD, RS 1994-12-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020241-006 LAMICTAL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1994-12-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020241-001 LAMICTAL 100MG TABLET / ORAL AB RLD 1994-12-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020241-002 LAMICTAL 150MG TABLET / ORAL AB RLD 1994-12-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020241-003 LAMICTAL 200MG TABLET / ORAL AB RLD 1994-12-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020241-004 LAMICTAL 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1994-12-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020241-005 LAMICTAL 25MG TABLET / ORAL AB RLD, RS 1994-12-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020241-006 LAMICTAL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1994-12-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020241-001 LAMICTAL 100MG TABLET / ORAL AB RLD 1994-12-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020241-002 LAMICTAL 150MG TABLET / ORAL AB RLD 1994-12-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020241-003 LAMICTAL 200MG TABLET / ORAL AB RLD 1994-12-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020241-004 LAMICTAL 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1994-12-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020241-005 LAMICTAL 25MG TABLET / ORAL AB RLD, RS 1994-12-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020241-006 LAMICTAL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1994-12-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020241-001 LAMICTAL 100MG TABLET / ORAL AB RLD 1994-12-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020241-002 LAMICTAL 150MG TABLET / ORAL AB RLD 1994-12-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020241-003 LAMICTAL 200MG TABLET / ORAL AB RLD 1994-12-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020241-004 LAMICTAL 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1994-12-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020241-005 LAMICTAL 25MG TABLET / ORAL AB RLD, RS 1994-12-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020241-006 LAMICTAL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1994-12-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020241-001 LAMICTAL 100MG TABLET / ORAL AB RLD 1994-12-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020241-002 LAMICTAL 150MG TABLET / ORAL AB RLD 1994-12-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020241-003 LAMICTAL 200MG TABLET / ORAL AB RLD 1994-12-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020241-004 LAMICTAL 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1994-12-27 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LAMOTRIGINE ACTIVE INGREDIENT U3H27498KS LAMICTAL (LAMOTRIGINE) TABLET [PD-RX PHARMACEUTICALS, INC.] 13 LAMOTRIGINE ACTIVE MOIETY U3H27498KS LAMICTAL (LAMOTRIGINE) TABLET [PD-RX PHARMACEUTICALS, INC.] 13 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LAMICTAL (LAMOTRIGINE) TABLET [PD-RX PHARMACEUTICALS, INC.] 13 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 LAMICTAL (LAMOTRIGINE) TABLET [PD-RX PHARMACEUTICALS, INC.] 13 LACTOSE INACTIVE INGREDIENT J2B2A4N98G LAMICTAL (LAMOTRIGINE) TABLET [PD-RX PHARMACEUTICALS, INC.] 13 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LAMICTAL (LAMOTRIGINE) TABLET [PD-RX PHARMACEUTICALS, INC.] 13 POVIDONE INACTIVE INGREDIENT FZ989GH94E LAMICTAL (LAMOTRIGINE) TABLET [PD-RX PHARMACEUTICALS, INC.] 13 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 LAMICTAL (LAMOTRIGINE) TABLET [PD-RX PHARMACEUTICALS, INC.] 13
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join LAMICTAL LAMOTRIGINE GlaxoSmithKline LLC d7e3572d-56fe-4727-2bb4-013ccca22678 2025-10-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020241 application number: NDA020241
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55289-410-30 55289041030 30 TABLET in 1 BOTTLE, PLASTIC (55289-410-30) 30 tablet 2011-12-19 0000-00-00 No No Current