Home NDC 63629-4697-2 Lamotrigine
Product NDC 63629-4697
Requested package NDC 63629-4697-2
11-digit product format 636294697
Labeler code 63629
Product ID 63629-4697_e4c53c49-1846-4473-a793-6c9d23b70260
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lamotrigine
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA079132
Marketing category ANDA
Marketing start 2009-01-27
Substance LAMOTRIGINE
Active strength 150 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 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 · 14 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A079132-001 LAMOTRIGINE LAMOTRIGINE 25MG TABLET / ORAL AB 2009-01-27 A079132-002 LAMOTRIGINE LAMOTRIGINE 100MG TABLET / ORAL AB 2009-01-27 A079132-003 LAMOTRIGINE LAMOTRIGINE 150MG TABLET / ORAL AB 2009-01-27 A079132-004 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.
Product history page 1 of 5 · 172 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 2026-09-14 22:38:34 2026-08 A079132-001 LAMOTRIGINE 25MG TABLET / ORAL AB 2009-01-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A079132-002 LAMOTRIGINE 100MG TABLET / ORAL AB 2009-01-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A079132-003 LAMOTRIGINE 150MG TABLET / ORAL AB 2009-01-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A079132-004 LAMOTRIGINE 200MG TABLET / ORAL AB 2009-01-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A079132-001 LAMOTRIGINE 25MG TABLET / ORAL AB 2009-01-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079132-002 LAMOTRIGINE 100MG TABLET / ORAL AB 2009-01-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079132-003 LAMOTRIGINE 150MG TABLET / ORAL AB 2009-01-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079132-004 LAMOTRIGINE 200MG TABLET / ORAL AB 2009-01-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A079132-001 LAMOTRIGINE 25MG TABLET / ORAL AB 2009-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079132-002 LAMOTRIGINE 100MG TABLET / ORAL AB 2009-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079132-003 LAMOTRIGINE 150MG TABLET / ORAL AB 2009-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079132-004 LAMOTRIGINE 200MG TABLET / ORAL AB 2009-01-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079132-001 LAMOTRIGINE 25MG TABLET / ORAL AB 2009-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079132-002 LAMOTRIGINE 100MG TABLET / ORAL AB 2009-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079132-003 LAMOTRIGINE 150MG TABLET / ORAL AB 2009-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079132-004 LAMOTRIGINE 200MG TABLET / ORAL AB 2009-01-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079132-001 LAMOTRIGINE 25MG TABLET / ORAL AB 2009-01-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079132-002 LAMOTRIGINE 100MG TABLET / ORAL AB 2009-01-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079132-003 LAMOTRIGINE 150MG TABLET / ORAL AB 2009-01-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079132-004 LAMOTRIGINE 200MG TABLET / ORAL AB 2009-01-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079132-001 LAMOTRIGINE 25MG TABLET / ORAL AB 2009-01-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079132-002 LAMOTRIGINE 100MG TABLET / ORAL AB 2009-01-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079132-003 LAMOTRIGINE 150MG TABLET / ORAL AB 2009-01-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079132-004 LAMOTRIGINE 200MG TABLET / ORAL AB 2009-01-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079132-001 LAMOTRIGINE 25MG TABLET / ORAL AB 2009-01-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079132-002 LAMOTRIGINE 100MG TABLET / ORAL AB 2009-01-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079132-003 LAMOTRIGINE 150MG TABLET / ORAL AB 2009-01-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079132-004 LAMOTRIGINE 200MG TABLET / ORAL AB 2009-01-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079132-001 LAMOTRIGINE 25MG TABLET / ORAL AB 2009-01-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079132-002 LAMOTRIGINE 100MG TABLET / ORAL AB 2009-01-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079132-003 LAMOTRIGINE 150MG TABLET / ORAL AB 2009-01-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079132-004 LAMOTRIGINE 200MG TABLET / ORAL AB 2009-01-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079132-001 LAMOTRIGINE 25MG TABLET / ORAL AB 2009-01-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079132-002 LAMOTRIGINE 100MG TABLET / ORAL AB 2009-01-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079132-003 LAMOTRIGINE 150MG TABLET / ORAL AB 2009-01-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079132-004 LAMOTRIGINE 200MG TABLET / ORAL AB 2009-01-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079132-001 LAMOTRIGINE 25MG TABLET / ORAL AB 2009-01-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079132-002 LAMOTRIGINE 100MG TABLET / ORAL AB 2009-01-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079132-003 LAMOTRIGINE 150MG TABLET / ORAL AB 2009-01-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079132-004 LAMOTRIGINE 200MG TABLET / ORAL AB 2009-01-27 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Lamotrigine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LAMOTRIGINE 150 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U3H27498KS Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198428 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 63629-4697-1 2025-09-04 These 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 63629-4697-2 2025-09-04 These 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 63629-4697-3 2025-09-04 These 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 63629-4697-4 2025-09-04 These 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 63629-4697-5 2025-09-04 These 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 63629-4697-1 2024-01-30 These 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 63629-4697-2 2024-01-30 These 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 63629-4697-3 2024-01-30 These 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 63629-4697-4 2024-01-30 These 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 63629-4697-5 2024-01-30 These 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 63629-4697-1 2022-02-16 These 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 63629-4697-1 2019-11-27 These 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
DailyMed Package Descriptions# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-4697 LAMOTRIGINE (LAMOTRIGINE) TABLET [BRYANT RANCH PREPACK] 1001 Current NDC, Legacy NDC, 5 package rows 20220217_d33c4293-347c-49a1-9d98-f291c3dab6da.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63629-4697-2 63629469702 30 TABLET in 1 BOTTLE (63629-4697-2) 30 tablet 2016-11-02 0000-00-00 No No Current