Lamotrigine
- Product NDC
- 68151-4249
- 11-digit product format
- 681514249
- Labeler code
- 68151
- Product ID
- 68151-4249_7e5d3d21-15dc-41c6-abf9-0834d4660965
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Carilion Materials Management
- Application
- ANDA076420
- Marketing category
- ANDA
- Marketing start
- 2006-08-28
- Marketing end
- 0000-00-00
- Substance
- LAMOTRIGINE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 68151-4249 | I | Inactivated by FDA | 2026-08-11 | ||
| excluded package | package | 68151-4249 | 68151-4249-0 | I | Inactivated by FDA | 2026-08-11 |
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.
| Captured / source date | Dataset | Scope | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68151-4249-0 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68151-4249-0 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68151-4249-0 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68151-4249-0 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68151-4249-0 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68151-4249-0 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | I | Inactivated by FDA | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68151-4249-0 | I | Inactivated by FDA | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | I | Inactivated by FDA | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68151-4249-0 | I | Inactivated by FDA | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | I | Inactivated by FDA | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68151-4249-0 | I | Inactivated by FDA | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 68151-4249-0 | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 68151-4249-0 | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 68151-4249-0 | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 68151-4249-0 | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 68151-4249-0 | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 68151-4249-0 | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 68151-4249-0 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 68151-4249-0 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 68151-4249-0 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 68151-4249-0 | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 68151-4249-0 | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 68151-4249-0 | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 68151-4249-0 | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076420-001 | LAMOTRIGINE | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | ||
| A076420-002 | LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 |
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.
| 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 | A076420-001 | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076420-002 | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076420-001 | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076420-002 | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076420-001 | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076420-002 | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076420-001 | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076420-002 | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076420-001 | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076420-002 | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076420-001 | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076420-002 | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076420-001 | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076420-002 | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076420-001 | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076420-002 | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076420-001 | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076420-002 | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076420-001 | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076420-002 | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076420-001 | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076420-002 | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076420-001 | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076420-002 | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076420-001 | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076420-002 | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076420-001 | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076420-002 | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076420-001 | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076420-002 | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076420-001 | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076420-002 | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076420-001 | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076420-002 | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076420-001 | LAMOTRIGINE | 5MG | TABLET, CHEWABLE / ORAL | 2006-06-21 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076420-002 | LAMOTRIGINE | 25MG | TABLET, CHEWABLE / ORAL | 2006-06-21 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076420-001 | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076420-002 | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A076420-001 | LAMOTRIGINE | 5MG | TABLET, CHEWABLE / ORAL | 2006-06-21 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A076420-002 | LAMOTRIGINE | 25MG | TABLET, CHEWABLE / ORAL | 2006-06-21 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-07-19 19:46 UTC | 2019-07 | A076420-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A076420-002 | AB | 1 | ea99ee380514… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 14a9502b-3d70-0496-a7e1-b16edaa005b8 | Product name | 5 | 20250423 |
| 16d731ed-ff3e-e9a1-3e3e-1ef6b6be40a0 | Product name | 7 | 20250401 |
| e29d8e8b-4bc8-ebaf-f18e-e35287b19d6a | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68151-4249-0 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-f473-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use LAMOTRIGINE TABLETS (CHEWABLE, DISPERSIBLE) safely and effectively. See full prescribing information for LAMOTRIGINE TABLETS (CHEWABLE, DISPERSIBLE). LAMOTRIGINE tablets (chewable, dispersible) for oral use Initial U.S. Approval: 1994 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68151-4249-0 | Lamotrigine | 1 in 1 PACKAGE | TABLET, CHEWABLE | 1 | 3 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68151-4249 | LAMOTRIGINE TABLET, CHEWABLE [CARILION MATERIALS MANAGEMENT] | 3 | Legacy NDC, 1 package rows | 20160806_a7455849-968d-4d85-8733-1e01701d7942.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 311265 | lamoTRIgine 5 MG Tablet for Oral Suspension | PSN | a7455849-968d-4d85-8733-1e01701d7942 | 3 |
| 311265 | lamotrigine 5 MG Tablet for Oral Suspension | SCD | a7455849-968d-4d85-8733-1e01701d7942 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 68151-4249-0 | 68151424900 | 1 in 1 PACKAGE | Historical |