Home NDC 68071-3944-6 Lamotrigine
Product NDC 68071-3944
Requested package NDC 68071-3944-6
11-digit product format 680713944
Labeler code 68071
Product ID 68071-3944_47fd2f9b-da67-9944-e063-6394a90a91c0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lamotrigine
Dosage form TABLET
Route ORAL
Labeler NuCare Pharmaceuticals, Inc.
Application ANDA078525
Marketing category ANDA
Marketing start 2009-01-27
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 2027-12-31
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 100 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 198427 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 68071-3944-6 Lamotrigine 60 in 1 BOTTLE TABLET 60 1
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 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 ndc (package): 68071-3944-6 ndc (product): 68071-3944 ndc11 (package): 68071394406
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68071-3944-6 68071394406 60 TABLET in 1 BOTTLE (68071-3944-6) 60 tablet 2026-01-09 No No Current