Home NDC 59115-065 Lamotrigine
Product NDC 59115-065
11-digit product format 591150065
Labeler code 59115
Product ID 59115-065_9d63c23d-d4d7-4abc-93a2-f9269abdad34
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lamotrigine
Dosage form TABLET
Route ORAL
Labeler Hikma Pharmaceutical
Application ANDA078134
Marketing category ANDA
Marketing start 2011-04-19
Marketing end 0000-00-00
Substance LAMOTRIGINE
Active strength 25 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 2020-12-31
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 A078134-001 LAMOTRIGINE LAMOTRIGINE 25MG TABLET / ORAL 2011-04-19 A078134-002 LAMOTRIGINE LAMOTRIGINE 100MG TABLET / ORAL 2011-04-19 A078134-003 LAMOTRIGINE LAMOTRIGINE 150MG TABLET / ORAL 2011-04-19 A078134-004 LAMOTRIGINE LAMOTRIGINE 200MG TABLET / ORAL 2011-04-19
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 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 A078134-001 LAMOTRIGINE 25MG TABLET / ORAL 2011-04-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078134-002 LAMOTRIGINE 100MG TABLET / ORAL 2011-04-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078134-003 LAMOTRIGINE 150MG TABLET / ORAL 2011-04-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078134-004 LAMOTRIGINE 200MG TABLET / ORAL 2011-04-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078134-001 LAMOTRIGINE 25MG TABLET / ORAL 2011-04-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078134-002 LAMOTRIGINE 100MG TABLET / ORAL 2011-04-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078134-003 LAMOTRIGINE 150MG TABLET / ORAL 2011-04-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078134-004 LAMOTRIGINE 200MG TABLET / ORAL 2011-04-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078134-001 LAMOTRIGINE 25MG TABLET / ORAL 2011-04-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078134-002 LAMOTRIGINE 100MG TABLET / ORAL 2011-04-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078134-003 LAMOTRIGINE 150MG TABLET / ORAL 2011-04-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078134-004 LAMOTRIGINE 200MG TABLET / ORAL 2011-04-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078134-001 LAMOTRIGINE 25MG TABLET / ORAL 2011-04-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078134-002 LAMOTRIGINE 100MG TABLET / ORAL 2011-04-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078134-003 LAMOTRIGINE 150MG TABLET / ORAL 2011-04-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078134-004 LAMOTRIGINE 200MG TABLET / ORAL 2011-04-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078134-001 LAMOTRIGINE 25MG TABLET / ORAL 2011-04-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078134-002 LAMOTRIGINE 100MG TABLET / ORAL 2011-04-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078134-003 LAMOTRIGINE 150MG TABLET / ORAL 2011-04-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078134-004 LAMOTRIGINE 200MG TABLET / ORAL 2011-04-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078134-001 LAMOTRIGINE 25MG TABLET / ORAL 2011-04-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078134-002 LAMOTRIGINE 100MG TABLET / ORAL 2011-04-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078134-003 LAMOTRIGINE 150MG TABLET / ORAL 2011-04-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078134-004 LAMOTRIGINE 200MG TABLET / ORAL 2011-04-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078134-001 LAMOTRIGINE 25MG TABLET / ORAL 2011-04-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078134-002 LAMOTRIGINE 100MG TABLET / ORAL 2011-04-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078134-003 LAMOTRIGINE 150MG TABLET / ORAL 2011-04-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078134-004 LAMOTRIGINE 200MG TABLET / ORAL 2011-04-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078134-001 LAMOTRIGINE 25MG TABLET / ORAL 2011-04-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078134-002 LAMOTRIGINE 100MG TABLET / ORAL 2011-04-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078134-003 LAMOTRIGINE 150MG TABLET / ORAL 2011-04-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078134-004 LAMOTRIGINE 200MG TABLET / ORAL 2011-04-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078134-001 LAMOTRIGINE 25MG TABLET / ORAL 2011-04-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078134-002 LAMOTRIGINE 100MG TABLET / ORAL 2011-04-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078134-003 LAMOTRIGINE 150MG TABLET / ORAL 2011-04-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078134-004 LAMOTRIGINE 200MG TABLET / ORAL 2011-04-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078134-001 LAMOTRIGINE 25MG TABLET / ORAL 2011-04-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078134-002 LAMOTRIGINE 100MG TABLET / ORAL 2011-04-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078134-003 LAMOTRIGINE 150MG TABLET / ORAL 2011-04-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078134-004 LAMOTRIGINE 200MG TABLET / ORAL 2011-04-19 d06236e962d9…
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