Home NDC 72189-063 LAMOTRIGINE
Product NDC 72189-063
11-digit product format 721890063
Labeler code 72189
Product ID 72189-063_2c4eb5ab-60c5-a669-e063-6394a90a27fa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LAMOTRIGINE
Dosage form TABLET
Route ORAL
Labeler DIRECT RX
Application ANDA090170
Marketing category ANDA
Marketing start 2020-06-16
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 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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 72189-063-30 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 72189-063-30 0efc9e666f02…f202fb6c5f17…
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 A090170-001 LAMOTRIGINE LAMOTRIGINE 25MG TABLET / ORAL AB 2011-10-06 A090170-002 LAMOTRIGINE LAMOTRIGINE 100MG TABLET / ORAL AB 2011-10-06 A090170-003 LAMOTRIGINE LAMOTRIGINE 150MG TABLET / ORAL AB 2011-10-06 A090170-004 LAMOTRIGINE LAMOTRIGINE 200MG TABLET / ORAL AB 2011-10-06
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 A090170-001 LAMOTRIGINE 25MG TABLET / ORAL AB 2011-10-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090170-002 LAMOTRIGINE 100MG TABLET / ORAL AB 2011-10-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090170-003 LAMOTRIGINE 150MG TABLET / ORAL AB 2011-10-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090170-004 LAMOTRIGINE 200MG TABLET / ORAL AB 2011-10-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090170-001 LAMOTRIGINE 25MG TABLET / ORAL AB 2011-10-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090170-002 LAMOTRIGINE 100MG TABLET / ORAL AB 2011-10-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090170-003 LAMOTRIGINE 150MG TABLET / ORAL AB 2011-10-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090170-004 LAMOTRIGINE 200MG TABLET / ORAL AB 2011-10-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090170-001 LAMOTRIGINE 25MG TABLET / ORAL AB 2011-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090170-002 LAMOTRIGINE 100MG TABLET / ORAL AB 2011-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090170-003 LAMOTRIGINE 150MG TABLET / ORAL AB 2011-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090170-004 LAMOTRIGINE 200MG TABLET / ORAL AB 2011-10-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090170-001 LAMOTRIGINE 25MG TABLET / ORAL AB 2011-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090170-002 LAMOTRIGINE 100MG TABLET / ORAL AB 2011-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090170-003 LAMOTRIGINE 150MG TABLET / ORAL AB 2011-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090170-004 LAMOTRIGINE 200MG TABLET / ORAL AB 2011-10-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090170-001 LAMOTRIGINE 25MG TABLET / ORAL AB 2011-10-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090170-002 LAMOTRIGINE 100MG TABLET / ORAL AB 2011-10-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090170-003 LAMOTRIGINE 150MG TABLET / ORAL AB 2011-10-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090170-004 LAMOTRIGINE 200MG TABLET / ORAL AB 2011-10-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090170-001 LAMOTRIGINE 25MG TABLET / ORAL AB 2011-10-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090170-002 LAMOTRIGINE 100MG TABLET / ORAL AB 2011-10-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090170-003 LAMOTRIGINE 150MG TABLET / ORAL AB 2011-10-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090170-004 LAMOTRIGINE 200MG TABLET / ORAL AB 2011-10-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090170-001 LAMOTRIGINE 25MG TABLET / ORAL AB 2011-10-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090170-002 LAMOTRIGINE 100MG TABLET / ORAL AB 2011-10-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090170-003 LAMOTRIGINE 150MG TABLET / ORAL AB 2011-10-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090170-004 LAMOTRIGINE 200MG TABLET / ORAL AB 2011-10-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090170-001 LAMOTRIGINE 25MG TABLET / ORAL AB 2011-10-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090170-002 LAMOTRIGINE 100MG TABLET / ORAL AB 2011-10-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090170-003 LAMOTRIGINE 150MG TABLET / ORAL AB 2011-10-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090170-004 LAMOTRIGINE 200MG TABLET / ORAL AB 2011-10-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090170-001 LAMOTRIGINE 25MG TABLET / ORAL AB 2011-10-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090170-002 LAMOTRIGINE 100MG TABLET / ORAL AB 2011-10-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090170-003 LAMOTRIGINE 150MG TABLET / ORAL AB 2011-10-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090170-004 LAMOTRIGINE 200MG TABLET / ORAL AB 2011-10-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090170-001 LAMOTRIGINE 25MG TABLET / ORAL AB 2011-10-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090170-002 LAMOTRIGINE 100MG TABLET / ORAL AB 2011-10-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090170-003 LAMOTRIGINE 150MG TABLET / ORAL AB 2011-10-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090170-004 LAMOTRIGINE 200MG TABLET / ORAL AB 2011-10-06 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 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 72189-063-30 LAMOTRIGINE 30 in 1 BOTTLE TABLET 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72189-063 LAMOTRIGINE TABLET [DIRECT RX] 2 Current NDC, Legacy NDC, 1 package rows 20250123_a835b697-2beb-1ba8-e053-2995a90a470c.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 2 of 2 · 24 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lamotrigine LAMOTRIGINE Proficient Rx LP 6f7e59d2-4311-42a0-93a0-b29b0417d96f 2024-02-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090170 application number: ANDA090170 Lamotrigine LAMOTRIGINE Proficient Rx LP 52273d60-3f27-4846-bf40-014ebcf09417 2022-05-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090170 application number: ANDA090170 Lamotrigine LAMOTRIGINE Proficient Rx LP b94ae2e4-e276-40c1-bc25-da980194fc99 2022-04-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090170 application number: ANDA090170 Lamotrigine LAMOTRIGINE Asclemed USA, Inc. 8ac9dc83-edb2-4ae5-8064-40f113fd3aab 2020-10-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090170 application number: ANDA090170
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 72189-063-30 72189006330 30 TABLET in 1 BOTTLE (72189-063-30) 30 tablet 2020-06-16 0000-00-00 No No Current