Home NDC 51672-4133-2 Lamotrigine
Product NDC 51672-4133
Requested package NDC 51672-4133-2
11-digit product format 516724133
Labeler code 51672
Product ID 51672-4133_44812d3c-0fc0-67dd-e063-6394a90a9d70
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lamotrigine
Dosage form TABLET
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA078525
Marketing category ANDA
Marketing start 2009-01-27
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 2026-12-31
Current FDA listing Yes 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 A078525-001 LAMOTRIGINE LAMOTRIGINE 25MG TABLET / ORAL AB 2009-01-27 A078525-002 LAMOTRIGINE LAMOTRIGINE 100MG TABLET / ORAL AB 2009-01-27 A078525-003 LAMOTRIGINE LAMOTRIGINE 150MG TABLET / ORAL AB 2009-01-27 A078525-004 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 · 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 A078525-001 LAMOTRIGINE 25MG TABLET / ORAL AB 2009-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078525-002 LAMOTRIGINE 100MG TABLET / ORAL AB 2009-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078525-003 LAMOTRIGINE 150MG TABLET / ORAL AB 2009-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078525-004 LAMOTRIGINE 200MG TABLET / ORAL AB 2009-01-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078525-001 LAMOTRIGINE 25MG TABLET / ORAL AB 2009-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078525-002 LAMOTRIGINE 100MG TABLET / ORAL AB 2009-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078525-003 LAMOTRIGINE 150MG TABLET / ORAL AB 2009-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078525-004 LAMOTRIGINE 200MG TABLET / ORAL AB 2009-01-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078525-001 LAMOTRIGINE 25MG TABLET / ORAL AB 2009-01-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078525-002 LAMOTRIGINE 100MG TABLET / ORAL AB 2009-01-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078525-003 LAMOTRIGINE 150MG TABLET / ORAL AB 2009-01-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078525-004 LAMOTRIGINE 200MG TABLET / ORAL AB 2009-01-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078525-001 LAMOTRIGINE 25MG TABLET / ORAL AB 2009-01-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078525-002 LAMOTRIGINE 100MG TABLET / ORAL AB 2009-01-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078525-003 LAMOTRIGINE 150MG TABLET / ORAL AB 2009-01-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078525-004 LAMOTRIGINE 200MG TABLET / ORAL AB 2009-01-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078525-001 LAMOTRIGINE 25MG TABLET / ORAL AB 2009-01-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078525-002 LAMOTRIGINE 100MG TABLET / ORAL AB 2009-01-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078525-003 LAMOTRIGINE 150MG TABLET / ORAL AB 2009-01-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078525-004 LAMOTRIGINE 200MG TABLET / ORAL AB 2009-01-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078525-001 LAMOTRIGINE 25MG TABLET / ORAL AB 2009-01-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078525-002 LAMOTRIGINE 100MG TABLET / ORAL AB 2009-01-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078525-003 LAMOTRIGINE 150MG TABLET / ORAL AB 2009-01-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078525-004 LAMOTRIGINE 200MG TABLET / ORAL AB 2009-01-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078525-001 LAMOTRIGINE 25MG TABLET / ORAL AB 2009-01-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078525-002 LAMOTRIGINE 100MG TABLET / ORAL AB 2009-01-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078525-003 LAMOTRIGINE 150MG TABLET / ORAL AB 2009-01-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078525-004 LAMOTRIGINE 200MG TABLET / ORAL AB 2009-01-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078525-001 LAMOTRIGINE 25MG TABLET / ORAL AB 2009-01-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078525-002 LAMOTRIGINE 100MG TABLET / ORAL AB 2009-01-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078525-003 LAMOTRIGINE 150MG TABLET / ORAL AB 2009-01-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078525-004 LAMOTRIGINE 200MG TABLET / ORAL AB 2009-01-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078525-001 LAMOTRIGINE 25MG TABLET / ORAL AB 2009-01-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078525-002 LAMOTRIGINE 100MG TABLET / ORAL AB 2009-01-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078525-003 LAMOTRIGINE 150MG TABLET / ORAL AB 2009-01-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078525-004 LAMOTRIGINE 200MG TABLET / ORAL AB 2009-01-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078525-001 LAMOTRIGINE 25MG TABLET / ORAL AB 2009-01-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078525-002 LAMOTRIGINE 100MG TABLET / ORAL AB 2009-01-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078525-003 LAMOTRIGINE 150MG TABLET / ORAL AB 2009-01-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078525-004 LAMOTRIGINE 200MG TABLET / ORAL AB 2009-01-27 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Lamotrigine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LAMOTRIGINE 200 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# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Lamotrigine ACTIVE INGREDIENT U3H27498KS LAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 8 Lamotrigine ACTIVE MOIETY U3H27498KS LAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 8 Aluminum Oxide INACTIVE INGREDIENT LMI26O6933 LAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 8 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U LAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 8 Croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 LAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 8 crospovidone INACTIVE INGREDIENT 68401960MK LAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 8 FD&C Blue No. 2 INACTIVE INGREDIENT L06K8R7DQK LAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 8 FD&C Yellow No. 6 INACTIVE INGREDIENT H77VEI93A8 LAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 8 ferric oxide yellow INACTIVE INGREDIENT EX438O2MRT LAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 8 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X LAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 8 magnesium stearate INACTIVE INGREDIENT 70097M6I30 LAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 8 povidones INACTIVE INGREDIENT FZ989GH94E LAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 8 Lamotrigine ACTIVE INGREDIENT U3H27498KS LAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP] 1 Lamotrigine ACTIVE MOIETY U3H27498KS LAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP] 1 Aluminum Oxide INACTIVE INGREDIENT LMI26O6933 LAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP] 1 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U LAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP] 1 Croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 LAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP] 1 crospovidone INACTIVE INGREDIENT 68401960MK LAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP] 1 FD&C Blue NO. 2 INACTIVE INGREDIENT L06K8R7DQK LAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 LAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP] 1 ferric oxide yellow INACTIVE INGREDIENT EX438O2MRT LAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP] 1 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X LAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 LAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP] 1 povidone INACTIVE INGREDIENT FZ989GH94E LAMOTRIGINE TABLET [REBEL DISTRIBUTORS CORP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-4133 LAMOTRIGINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 15 Current NDC, Legacy NDC, 7 package rows 20230517_b829f9b2-f0ac-408a-a6f4-18b72150227d.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lamotrigine LAMOTRIGINE Sun Pharmaceutical Industries, Inc. b829f9b2-f0ac-408a-a6f4-18b72150227d 2026-06-03 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078525 application number: ANDA078525 ndc (package): 51672-4133-2 ndc (product): 51672-4133 ndc11 (package): 51672413302 Lamotrigine LAMOTRIGINE Bryant Ranch Prepack 68a4dac2-5015-40c5-88ca-204098c3b288 2026-05-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078525 application number: ANDA078525 Lamotrigine LAMOTRIGINE NuCare Pharmaceuticals, Inc. 47fd2592-2fc6-9787-e063-6394a90a8f01 2026-01-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078525 application number: ANDA078525
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 51672-4133-2 51672413302 500 TABLET in 1 BOTTLE (51672-4133-2) 500 tablet 2022-10-25 0000-00-00 No No Current