LAMICTAL
- Product NDC
- 0173-0778
- 11-digit product format
- 001730778
- Labeler code
- 0173
- Product ID
- 0173-0778_4492fd3c-e068-4599-8a10-0b26ea2a4f91
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lamotrigine
- Dosage form
- KIT
- Labeler
- GlaxoSmithKline LLC
- Application
- NDA022251
- Marketing category
- NDA
- Marketing start
- 2009-06-05
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022251-001 | LAMICTAL ODT | LAMOTRIGINE | 25MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2009-05-08 |
| N022251-002 | LAMICTAL ODT | LAMOTRIGINE | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD, RS | 2009-05-08 |
| N022251-003 | LAMICTAL ODT | LAMOTRIGINE | 100MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2009-05-08 |
| N022251-004 | LAMICTAL ODT | LAMOTRIGINE | 200MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2009-05-08 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N022251-001 | AB |
| N022251-002 | AB |
| N022251-003 | AB |
| N022251-004 | AB |
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 | N022251-001 | LAMICTAL ODT | 25MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2009-05-08 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022251-002 | LAMICTAL ODT | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD, RS | 2009-05-08 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022251-003 | LAMICTAL ODT | 100MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2009-05-08 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022251-004 | LAMICTAL ODT | 200MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2009-05-08 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022251-001 | LAMICTAL ODT | 25MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2009-05-08 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022251-002 | LAMICTAL ODT | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD, RS | 2009-05-08 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022251-003 | LAMICTAL ODT | 100MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2009-05-08 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022251-004 | LAMICTAL ODT | 200MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2009-05-08 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022251-001 | LAMICTAL ODT | 25MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2009-05-08 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022251-002 | LAMICTAL ODT | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD, RS | 2009-05-08 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022251-003 | LAMICTAL ODT | 100MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2009-05-08 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022251-004 | LAMICTAL ODT | 200MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2009-05-08 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022251-001 | LAMICTAL ODT | 25MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2009-05-08 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022251-002 | LAMICTAL ODT | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD, RS | 2009-05-08 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022251-003 | LAMICTAL ODT | 100MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2009-05-08 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022251-004 | LAMICTAL ODT | 200MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2009-05-08 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022251-001 | LAMICTAL ODT | 25MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2009-05-08 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022251-002 | LAMICTAL ODT | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD, RS | 2009-05-08 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022251-003 | LAMICTAL ODT | 100MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2009-05-08 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022251-004 | LAMICTAL ODT | 200MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2009-05-08 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022251-001 | LAMICTAL ODT | 25MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2009-05-08 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022251-002 | LAMICTAL ODT | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD, RS | 2009-05-08 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022251-003 | LAMICTAL ODT | 100MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2009-05-08 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022251-004 | LAMICTAL ODT | 200MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2009-05-08 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022251-001 | LAMICTAL ODT | 25MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2009-05-08 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022251-002 | LAMICTAL ODT | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD, RS | 2009-05-08 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022251-003 | LAMICTAL ODT | 100MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2009-05-08 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022251-004 | LAMICTAL ODT | 200MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2009-05-08 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022251-001 | LAMICTAL ODT | 25MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2009-05-08 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022251-002 | LAMICTAL ODT | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD, RS | 2009-05-08 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022251-003 | LAMICTAL ODT | 100MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2009-05-08 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022251-004 | LAMICTAL ODT | 200MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2009-05-08 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022251-001 | LAMICTAL ODT | 25MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2009-05-08 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022251-002 | LAMICTAL ODT | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD, RS | 2009-05-08 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022251-003 | LAMICTAL ODT | 100MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2009-05-08 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022251-004 | LAMICTAL ODT | 200MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2009-05-08 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N022251-001 | LAMICTAL ODT | 25MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2009-05-08 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022251-002 | LAMICTAL ODT | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD, RS | 2009-05-08 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022251-003 | LAMICTAL ODT | 100MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2009-05-08 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022251-004 | LAMICTAL ODT | 200MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RLD | 2009-05-08 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N022251-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022251-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022251-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022251-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022251-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022251-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022251-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022251-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022251-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022251-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022251-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022251-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022251-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022251-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022251-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022251-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022251-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022251-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022251-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022251-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022251-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022251-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022251-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022251-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022251-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022251-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022251-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022251-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022251-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022251-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022251-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022251-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022251-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022251-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022251-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022251-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N022251-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022251-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022251-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022251-004 | AB | 1 | d06236e962d9… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022251-001 | 8840925 | 2028-07-02 | U-1596 | Drug product | 2014-10-22 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022251-001 | 9339504 | 2028-07-02 | U-1596 | Drug product | 2016-06-09 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022251-001 | 7919115 | 2029-01-04 | Drug substance, Drug product | 2011-04-14 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022251-004 | 8840925 | 2028-07-02 | U-1596 | Drug product | 2014-10-22 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022251-004 | 9339504 | 2028-07-02 | U-1596 | Drug product | 2016-06-09 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022251-004 | 7919115 | 2029-01-04 | Drug substance, Drug product | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N022251-001 | 8840925 | 2028-07-02 | U-1596 | Drug product | 2014-10-22 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N022251-001 | 9339504 | 2028-07-02 | U-1596 | Drug product | 2016-06-09 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N022251-001 | 7919115 | 2029-01-04 | Drug substance, Drug product | 2011-04-14 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022251-004 | 8840925 | 2028-07-02 | U-1596 | Drug product | 2014-10-22 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N022251-004 | 9339504 | 2028-07-02 | U-1596 | Drug product | 2016-06-09 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N022251-004 | 7919115 | 2029-01-04 | Drug substance, Drug product | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N022251-001 | 8840925 | 2028-07-02 | U-1596 | Drug product | 2014-10-22 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N022251-001 | 9339504 | 2028-07-02 | U-1596 | Drug product | 2016-06-09 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N022251-001 | 7919115 | 2029-01-04 | Drug substance, Drug product | 2011-04-14 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N022251-004 | 8840925 | 2028-07-02 | U-1596 | Drug product | 2014-10-22 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N022251-004 | 9339504 | 2028-07-02 | U-1596 | Drug product | 2016-06-09 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N022251-004 | 7919115 | 2029-01-04 | Drug substance, Drug product | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N022251-001 | 8840925 | 2028-07-02 | U-1596 | Drug product | 2014-10-22 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022251-001 | 9339504 | 2028-07-02 | U-1596 | Drug product | 2016-06-09 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022251-001 | 7919115 | 2029-01-04 | Drug substance, Drug product | 2011-04-14 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N022251-004 | 8840925 | 2028-07-02 | U-1596 | Drug product | 2014-10-22 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022251-004 | 9339504 | 2028-07-02 | U-1596 | Drug product | 2016-06-09 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022251-004 | 7919115 | 2029-01-04 | Drug substance, Drug product | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N022251-001 | 8840925 | 2028-07-02 | U-1596 | Drug product | 2014-10-22 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N022251-001 | 9339504 | 2028-07-02 | U-1596 | Drug product | 2016-06-09 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N022251-001 | 7919115 | 2029-01-04 | Drug substance, Drug product | 2011-04-14 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N022251-004 | 8840925 | 2028-07-02 | U-1596 | Drug product | 2014-10-22 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N022251-004 | 9339504 | 2028-07-02 | U-1596 | Drug product | 2016-06-09 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N022251-004 | 7919115 | 2029-01-04 | Drug substance, Drug product | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N022251-001 | 8840925 | 2028-07-02 | U-1596 | Drug product | 2014-10-22 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N022251-001 | 9339504 | 2028-07-02 | U-1596 | Drug product | 2016-06-09 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N022251-001 | 7919115 | 2029-01-04 | Drug substance, Drug product | 2011-04-14 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N022251-004 | 8840925 | 2028-07-02 | U-1596 | Drug product | 2014-10-22 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N022251-004 | 9339504 | 2028-07-02 | U-1596 | Drug product | 2016-06-09 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N022251-004 | 7919115 | 2029-01-04 | Drug substance, Drug product | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022251-001 | 8840925 | 2028-07-02 | U-1596 | Drug product | 2014-10-22 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022251-001 | 9339504 | 2028-07-02 | U-1596 | Drug product | 2016-06-09 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022251-001 | 7919115 | 2029-01-04 | Drug substance, Drug product | 2011-04-14 | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022251-004 | 8840925 | 2028-07-02 | U-1596 | Drug product | 2014-10-22 | 87673890dc5c… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- LAMICTAL
- Brand name suffix
- ODT
- Listing expiration
- 2026-12-31
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| U3H27498KS | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 103968 | Internal RxNorm lookup |
| 105018 | Internal RxNorm lookup |
| 105019 | Internal RxNorm lookup |
| 108782 | Internal RxNorm lookup |
| 198427 | Internal RxNorm lookup |
| 198428 | Internal RxNorm lookup |
| 198429 | Internal RxNorm lookup |
| 198430 | Internal RxNorm lookup |
| 201239 | Internal RxNorm lookup |
| 201240 | Internal RxNorm lookup |
| 206201 | Internal RxNorm lookup |
| 252478 | Internal RxNorm lookup |
| 252479 | Internal RxNorm lookup |
| 282401 | Internal RxNorm lookup |
| 311264 | Internal RxNorm lookup |
| 311265 | Internal RxNorm lookup |
| 349010 | Internal RxNorm lookup |
| 542426 | Internal RxNorm lookup |
| 751139 | Internal RxNorm lookup |
| 751563 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| d7e3572d-56fe-4727-2bb4-013ccca22678 | Available on FDA.report |
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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0173-0778-00 | LAMICTALODT | 1 in 1 BLISTER PACK | KIT | 1 | 44 | |
| 0173-0778-00 | LAMICTALODT | 1 in 1 PACKAGE, COMBINATION | KIT | 1 | 44 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0173-0778-00 | EA - Each | 0173-0778 | 922cc499-1dd8-4c4a-b821-1c185b755c3c | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0173-0778 | LAMICTAL (LAMOTRIGINE) TABLET LAMICTAL (LAMOTRIGINE) TABLET, FOR SUSPENSION LAMICTAL ODT (LAMOTRIGINE) TABLET, ORALLY DISINTEGRATING LAMICTAL (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC] | 43 | Current NDC, Legacy NDC, 2 package rows | 20250507_d7e3572d-56fe-4727-2bb4-013ccca22678.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| LAMICTAL | LAMOTRIGINE | GlaxoSmithKline LLC | d7e3572d-56fe-4727-2bb4-013ccca22678 | 2025-10-10 | Boxed warning, Warnings, Adverse reactions | 022251 NDA022251 0173-0778 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 851753 | {14 (lamotrigine 100 MG Disintegrating Oral Tablet [Lamictal]) / 42 (lamotrigine 50 MG Disintegrating Oral Tablet [Lamictal]) } Pack [Lamictal ODT Green Titration Kit (for Patients Taking Enzyme-Inducing Drugs and Not Taking Valproate)] | BPCK | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 795778 | {14 (lamotrigine 100 MG Oral Tablet [Lamictal]) / 84 (lamotrigine 25 MG Oral Tablet [Lamictal]) } Pack [Lamictal Green (For Patients Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Rifampin and Not Taking Valproate)] | BPCK | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 851749 | {21 (lamotrigine 25 MG Disintegrating Oral Tablet [Lamictal]) / 7 (lamotrigine 50 MG Disintegrating Oral Tablet [Lamictal]) } Pack [Lamictal ODT Blue Patient Titration Kit (for Patients Taking Valproate)] | BPCK | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 795772 | {35 (lamotrigine 25 MG Oral Tablet [Lamictal]) } Pack [Lamictal Blue (For Patients Taking Valproate)] | BPCK | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 851751 | {7 (lamotrigine 100 MG Disintegrating Oral Tablet [Lamictal]) / 14 (lamotrigine 25 MG Disintegrating Oral Tablet [Lamictal]) / 14 (lamotrigine 50 MG Disintegrating Oral Tablet [Lamictal]) } Pack [Lamictal ODT Orange Patient Titration Kit (For Patients Not Taking Enzyme-Inducing Drugs or Valproate)] | BPCK | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 795774 | {7 (lamotrigine 100 MG Oral Tablet [Lamictal]) / 42 (lamotrigine 25 MG Oral Tablet [Lamictal]) } Pack [Lamictal Orange (For Patients Not Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Rifampin and Not Taking Valproate)] | BPCK | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 851752 | {14 (lamotrigine 100 MG Disintegrating Oral Tablet) / 42 (lamotrigine 50 MG Disintegrating Oral Tablet) } Pack | GPCK | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 753451 | {14 (lamotrigine 100 MG Oral Tablet) / 84 (lamotrigine 25 MG Oral Tablet) } Pack | GPCK | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 851748 | {21 (lamotrigine 25 MG Disintegrating Oral Tablet) / 7 (lamotrigine 50 MG Disintegrating Oral Tablet) } Pack | GPCK | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 751139 | {35 (lamotrigine 25 MG Oral Tablet) } Pack | GPCK | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 851750 | {7 (lamotrigine 100 MG Disintegrating Oral Tablet) / 14 (lamotrigine 25 MG Disintegrating Oral Tablet) / 14 (lamotrigine 50 MG Disintegrating Oral Tablet) } Pack | GPCK | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 751563 | {7 (lamotrigine 100 MG Oral Tablet) / 42 (lamotrigine 25 MG Oral Tablet) } Pack | GPCK | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 105018 | LaMICtal 100 MG Oral Tablet | PSN | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 206201 | LaMICtal 150 MG Oral Tablet | PSN | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 542426 | LaMICtal 2 MG Tablet for Oral Suspension | PSN | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 108782 | LaMICtal 200 MG Oral Tablet | PSN | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 105019 | LaMICtal 25 MG Oral Tablet | PSN | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 201240 | LaMICtal 25 MG Tablet for Oral Suspension | PSN | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 201239 | LaMICtal 5 MG Tablet for Oral Suspension | PSN | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 849049 | LaMICtal ODT 100 MG Disintegrating Oral Tablet | PSN | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 849050 | LaMICtal ODT 200 MG Disintegrating Oral Tablet | PSN | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 849051 | LaMICtal ODT 25 MG Disintegrating Oral Tablet | PSN | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 849052 | LaMICtal ODT 50 MG Disintegrating Oral Tablet | PSN | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 851749 | LaMICtal ODT Patient Titration Kit Blue 25 MG (21), 50 MG (7) 28 Count | PSN | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 851753 | LaMICtal ODT Patient Titration Kit Green 50 MG (42), 100 MG (14) 56 Count | PSN | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 851751 | LaMICtal ODT Patient Titration Kit Orange 25 MG (14), 50 MG (14), 100 MG (7) 35 Count | PSN | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 795772 | LaMICtal Starter Kit Blue 25 MG 35 Count | PSN | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 795778 | LaMICtal Starter Kit Green 25 MG (84), 100 MG (14) 98 Count | PSN | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 795774 | LaMICtal Starter Kit Orange 25 MG (42), 100 MG (7) 49 Count | PSN | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 103968 | lamoTRIgine 100 MG Disintegrating Oral Tablet | PSN | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 198427 | lamoTRIgine 100 MG Oral Tablet | PSN | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 198428 | lamoTRIgine 150 MG Oral Tablet | PSN | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 349010 | lamoTRIgine 2 MG Tablet for Oral Suspension | PSN | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 252479 | lamoTRIgine 200 MG Disintegrating Oral Tablet | PSN | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 198429 | lamoTRIgine 200 MG Oral Tablet | PSN | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 851750 | lamoTRIgine 25 MG (14), 50 MG (14), 100 MG (7) Disintegrating Oral Tablet 35 Count Pack | PSN | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 851748 | lamoTRIgine 25 MG (21), 50 MG (7) Disintegrating Oral Tablet 28 Count Pack | PSN | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 751563 | lamoTRIgine 25 MG (42), 100 MG (7) Oral Tablet 49 Count Pack | PSN | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 753451 | lamoTRIgine 25 MG (84), 100 MG (14) Oral Tablet 98 Count Pack | PSN | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 198430 | lamoTRIgine 25 MG Disintegrating Oral Tablet | PSN | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 282401 | lamoTRIgine 25 MG Oral Tablet | PSN | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 751139 | lamoTRIgine 25 MG Oral Tablet 35 Count Pack | PSN | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 311264 | lamoTRIgine 25 MG Tablet for Oral Suspension | PSN | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 311265 | lamoTRIgine 5 MG Tablet for Oral Suspension | PSN | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 851752 | lamoTRIgine 50 MG (42), 100 MG (14) Disintegrating Oral Tablet 56 Count Pack | PSN | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 252478 | lamoTRIgine 50 MG Disintegrating Oral Tablet | PSN | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 849049 | lamotrigine 100 MG Disintegrating Oral Tablet [Lamictal] | SBD | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 105018 | lamotrigine 100 MG Oral Tablet [Lamictal] | SBD | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 206201 | lamotrigine 150 MG Oral Tablet [Lamictal] | SBD | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 542426 | lamotrigine 2 MG Tablet for Oral Suspension [Lamictal] | SBD | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 849050 | lamotrigine 200 MG Disintegrating Oral Tablet [Lamictal] | SBD | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 108782 | lamotrigine 200 MG Oral Tablet [Lamictal] | SBD | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 849051 | lamotrigine 25 MG Disintegrating Oral Tablet [Lamictal] | SBD | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 105019 | lamotrigine 25 MG Oral Tablet [Lamictal] | SBD | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 201240 | lamotrigine 25 MG Tablet for Oral Suspension [Lamictal] | SBD | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 201239 | lamotrigine 5 MG Tablet for Oral Suspension [Lamictal] | SBD | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 849052 | lamotrigine 50 MG Disintegrating Oral Tablet [Lamictal] | SBD | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 103968 | lamotrigine 100 MG Disintegrating Oral Tablet | SCD | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 198427 | lamotrigine 100 MG Oral Tablet | SCD | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 198428 | lamotrigine 150 MG Oral Tablet | SCD | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 349010 | lamotrigine 2 MG Tablet for Oral Suspension | SCD | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 252479 | lamotrigine 200 MG Disintegrating Oral Tablet | SCD | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 198429 | lamotrigine 200 MG Oral Tablet | SCD | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 198430 | lamotrigine 25 MG Disintegrating Oral Tablet | SCD | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 282401 | lamotrigine 25 MG Oral Tablet | SCD | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 311264 | lamotrigine 25 MG Tablet for Oral Suspension | SCD | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 311265 | lamotrigine 5 MG Tablet for Oral Suspension | SCD | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 252478 | lamotrigine 50 MG Disintegrating Oral Tablet | SCD | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 105018 | Lamictal 100 MG Oral Tablet | SY | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 206201 | Lamictal 150 MG Oral Tablet | SY | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 542426 | Lamictal 2 MG Tablet for Oral Suspension | SY | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 108782 | Lamictal 200 MG Oral Tablet | SY | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 105019 | Lamictal 25 MG Oral Tablet | SY | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 795772 | Lamictal Blue (For Patients Taking Valproate) | SY | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 542426 | Lamictal CD 2 MG Tablet for Oral Suspension | SY | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 201240 | Lamictal CD 25 MG Tablet for Oral Suspension | SY | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 201239 | Lamictal CD 5 MG Tablet for Oral Suspension | SY | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 795778 | Lamictal Green Kit (For Patients Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Rifampin and Not Taking Valproate) | SY | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 849049 | Lamictal ODT 100 MG Disintegrating Oral Tablet | SY | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
| 849050 | Lamictal ODT 200 MG Disintegrating Oral Tablet | SY | d7e3572d-56fe-4727-2bb4-013ccca22678 | 44 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0173-0778-00 | 00173077800 | 1 BLISTER PACK in 1 PACKAGE, COMBINATION (0173-0778-00) / 1 KIT in 1 BLISTER PACK | 1 blister pack | 2009-06-05 | 0000-00-00 | No | No | Current |