Home NDC 42291-366 Lamotrigine
Product NDC 42291-366
11-digit product format 422910366
Labeler code 42291
Product ID 42291-366_51b57ded-2d7d-d540-e063-6394a90a4744
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lamotrigine
Dosage form TABLET
Route ORAL
Labeler AvKARE
Application ANDA079132
Marketing category ANDA
Marketing start 2013-04-10
Substance LAMOTRIGINE
Active strength 25 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 2027-12-31
Current FDA listing Yes 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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LAMOTRIGINE 25 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198427 Internal RxNorm lookup 198428 Internal RxNorm lookup 198429 Internal RxNorm lookup 282401 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42291-366-01 Lamotrigine 100 in 1 BOTTLE TABLET 100 17 42291-366-10 Lamotrigine 1000 in 1 BOTTLE TABLET 1000 17
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LAMOTRIGINE ACTIVE INGREDIENT U3H27498KS LAMOTRIGINE (LAMOTRIGINE) TABLET [AVKARE, INC.] 4 LAMOTRIGINE ACTIVE MOIETY U3H27498KS LAMOTRIGINE (LAMOTRIGINE) TABLET [AVKARE, INC.] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LAMOTRIGINE (LAMOTRIGINE) TABLET [AVKARE, INC.] 4 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X LAMOTRIGINE (LAMOTRIGINE) TABLET [AVKARE, INC.] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LAMOTRIGINE (LAMOTRIGINE) TABLET [AVKARE, INC.] 4 Starch, Corn INACTIVE INGREDIENT O8232NY3SJ LAMOTRIGINE (LAMOTRIGINE) TABLET [AVKARE, INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42291-366 LAMOTRIGINE TABLET [AVKARE] 15 Current NDC, Legacy NDC, 2 package rows 20220114_fcdb94a8-33be-6375-98ef-6933999d157f.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 42291-366-01 42291036601 100 TABLET in 1 BOTTLE (42291-366-01) 100 tablet 2013-04-10 0000-00-00 No No Current 42291-366-10 42291036610 1000 TABLET in 1 BOTTLE (42291-366-10) 1000 tablet 2015-01-28 0000-00-00 No No Current