Vimpat
- Product NDC
- 0131-2477
- 11-digit product format
- 001312477
- Labeler code
- 0131
- Product ID
- 0131-2477_51a12988-3e4b-c52b-e063-6394a90a7415
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lacosamide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- UCB, Inc.
- Application
- NDA022253
- Marketing category
- NDA
- Marketing start
- 2009-05-26
- Substance
- LACOSAMIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE]
- DEA schedule
- CV
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022253-001 | VIMPAT | LACOSAMIDE | 50MG | TABLET / ORAL | AB | RLD | 2008-10-28 |
| N022253-002 | VIMPAT | LACOSAMIDE | 100MG | TABLET / ORAL | AB | RLD | 2008-10-28 |
| N022253-003 | VIMPAT | LACOSAMIDE | 150MG | TABLET / ORAL | AB | RLD | 2008-10-28 |
| N022253-004 | VIMPAT | LACOSAMIDE | 200MG | TABLET / ORAL | AB | RLD, RS | 2008-10-28 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N022253-001 | AB |
| N022253-002 | AB |
| N022253-003 | AB |
| N022253-004 | AB |
Orange Book exclusivity#
| Application-product | Exclusivity code | Expiration |
|---|---|---|
| N022253-001 | D-188 | 2026-04-28 |
| N022253-002 | D-188 | 2026-04-28 |
| N022253-003 | D-188 | 2026-04-28 |
| N022253-004 | D-188 | 2026-04-28 |
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 | N022253-001 | VIMPAT | 50MG | TABLET / ORAL | AB | RLD | 2008-10-28 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022253-002 | VIMPAT | 100MG | TABLET / ORAL | AB | RLD | 2008-10-28 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022253-003 | VIMPAT | 150MG | TABLET / ORAL | AB | RLD | 2008-10-28 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022253-004 | VIMPAT | 200MG | TABLET / ORAL | AB | RLD, RS | 2008-10-28 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022253-001 | VIMPAT | 50MG | TABLET / ORAL | AB | RLD | 2008-10-28 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022253-002 | VIMPAT | 100MG | TABLET / ORAL | AB | RLD | 2008-10-28 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022253-003 | VIMPAT | 150MG | TABLET / ORAL | AB | RLD | 2008-10-28 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022253-004 | VIMPAT | 200MG | TABLET / ORAL | AB | RLD, RS | 2008-10-28 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022253-001 | VIMPAT | 50MG | TABLET / ORAL | AB | RLD | 2008-10-28 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022253-002 | VIMPAT | 100MG | TABLET / ORAL | AB | RLD | 2008-10-28 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022253-003 | VIMPAT | 150MG | TABLET / ORAL | AB | RLD | 2008-10-28 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022253-004 | VIMPAT | 200MG | TABLET / ORAL | AB | RLD, RS | 2008-10-28 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022253-001 | VIMPAT | 50MG | TABLET / ORAL | AB | RLD | 2008-10-28 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022253-002 | VIMPAT | 100MG | TABLET / ORAL | AB | RLD | 2008-10-28 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022253-003 | VIMPAT | 150MG | TABLET / ORAL | AB | RLD | 2008-10-28 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022253-004 | VIMPAT | 200MG | TABLET / ORAL | AB | RLD, RS | 2008-10-28 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022253-001 | VIMPAT | 50MG | TABLET / ORAL | AB | RLD | 2008-10-28 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022253-002 | VIMPAT | 100MG | TABLET / ORAL | AB | RLD | 2008-10-28 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022253-003 | VIMPAT | 150MG | TABLET / ORAL | AB | RLD | 2008-10-28 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022253-004 | VIMPAT | 200MG | TABLET / ORAL | AB | RLD, RS | 2008-10-28 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022253-001 | VIMPAT | 50MG | TABLET / ORAL | AB | RLD | 2008-10-28 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022253-002 | VIMPAT | 100MG | TABLET / ORAL | AB | RLD | 2008-10-28 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022253-003 | VIMPAT | 150MG | TABLET / ORAL | AB | RLD | 2008-10-28 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022253-004 | VIMPAT | 200MG | TABLET / ORAL | AB | RLD, RS | 2008-10-28 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022253-001 | VIMPAT | 50MG | TABLET / ORAL | AB | RLD | 2008-10-28 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022253-002 | VIMPAT | 100MG | TABLET / ORAL | AB | RLD | 2008-10-28 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022253-003 | VIMPAT | 150MG | TABLET / ORAL | AB | RLD | 2008-10-28 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022253-004 | VIMPAT | 200MG | TABLET / ORAL | AB | RLD, RS | 2008-10-28 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022253-001 | VIMPAT | 50MG | TABLET / ORAL | AB | RLD | 2008-10-28 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022253-002 | VIMPAT | 100MG | TABLET / ORAL | AB | RLD | 2008-10-28 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022253-003 | VIMPAT | 150MG | TABLET / ORAL | AB | RLD | 2008-10-28 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022253-004 | VIMPAT | 200MG | TABLET / ORAL | AB | RLD, RS | 2008-10-28 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022253-001 | VIMPAT | 50MG | TABLET / ORAL | AB | RLD | 2008-10-28 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022253-002 | VIMPAT | 100MG | TABLET / ORAL | AB | RLD | 2008-10-28 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022253-003 | VIMPAT | 150MG | TABLET / ORAL | AB | RLD | 2008-10-28 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022253-004 | VIMPAT | 200MG | TABLET / ORAL | AB | RLD, RS | 2008-10-28 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N022253-001 | VIMPAT | 50MG | TABLET / ORAL | AB | RLD | 2008-10-28 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022253-002 | VIMPAT | 100MG | TABLET / ORAL | AB | RLD | 2008-10-28 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022253-003 | VIMPAT | 150MG | TABLET / ORAL | AB | RLD | 2008-10-28 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022253-004 | VIMPAT | 200MG | TABLET / ORAL | AB | RLD, RS | 2008-10-28 | 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 | N022253-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022253-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022253-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022253-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022253-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022253-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022253-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022253-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022253-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022253-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022253-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022253-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022253-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022253-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022253-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022253-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022253-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022253-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022253-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022253-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022253-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022253-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022253-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022253-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022253-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022253-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022253-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022253-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022253-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022253-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022253-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022253-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022253-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022253-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022253-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022253-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N022253-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022253-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022253-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022253-004 | 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 | N022253-001 | RE38551 | 2022-03-17 | U-2140 | Drug substance, Drug product | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022253-001 | RE38551 | 2022-03-17 | U-1567 | Drug substance, Drug product | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022253-001 | RE38551 | 2022-03-17 | U-2999 | Drug substance, Drug product | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022253-001 | RE38551 | 2022-03-17 | U-2990 | Drug substance, Drug product | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022253-001 | RE38551 | 2022-03-17 | U-2989 | Drug substance, Drug product | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022253-002 | RE38551 | 2022-03-17 | U-1567 | Drug substance, Drug product | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022253-002 | RE38551 | 2022-03-17 | U-2999 | Drug substance, Drug product | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022253-002 | RE38551 | 2022-03-17 | U-2990 | Drug substance, Drug product | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022253-002 | RE38551 | 2022-03-17 | U-2989 | Drug substance, Drug product | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022253-002 | RE38551 | 2022-03-17 | U-2140 | Drug substance, Drug product | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022253-003 | RE38551 | 2022-03-17 | U-2140 | Drug substance, Drug product | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022253-003 | RE38551 | 2022-03-17 | U-2999 | Drug substance, Drug product | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022253-003 | RE38551 | 2022-03-17 | U-2989 | Drug substance, Drug product | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022253-003 | RE38551 | 2022-03-17 | U-2990 | Drug substance, Drug product | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022253-003 | RE38551 | 2022-03-17 | U-1567 | Drug substance, Drug product | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022253-004 | RE38551 | 2022-03-17 | U-2140 | Drug substance, Drug product | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022253-004 | RE38551 | 2022-03-17 | U-1567 | Drug substance, Drug product | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022253-004 | RE38551 | 2022-03-17 | U-2999 | Drug substance, Drug product | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022253-004 | RE38551 | 2022-03-17 | U-2989 | Drug substance, Drug product | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022253-004 | RE38551 | 2022-03-17 | U-2990 | Drug substance, Drug product | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022253-001 | RE38551 | 2022-03-17 | U-2140 | Drug substance, Drug product | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022253-001 | RE38551 | 2022-03-17 | U-1567 | Drug substance, Drug product | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022253-001 | RE38551 | 2022-03-17 | U-2999 | Drug substance, Drug product | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022253-001 | RE38551 | 2022-03-17 | U-2990 | Drug substance, Drug product | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022253-001 | RE38551 | 2022-03-17 | U-2989 | Drug substance, Drug product | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022253-002 | RE38551 | 2022-03-17 | U-1567 | Drug substance, Drug product | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022253-002 | RE38551 | 2022-03-17 | U-2999 | Drug substance, Drug product | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022253-002 | RE38551 | 2022-03-17 | U-2990 | Drug substance, Drug product | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022253-002 | RE38551 | 2022-03-17 | U-2989 | Drug substance, Drug product | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022253-002 | RE38551 | 2022-03-17 | U-2140 | Drug substance, Drug product | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022253-003 | RE38551 | 2022-03-17 | U-2140 | Drug substance, Drug product | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022253-003 | RE38551 | 2022-03-17 | U-2999 | Drug substance, Drug product | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022253-003 | RE38551 | 2022-03-17 | U-2989 | Drug substance, Drug product | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022253-003 | RE38551 | 2022-03-17 | U-2990 | Drug substance, Drug product | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022253-003 | RE38551 | 2022-03-17 | U-1567 | Drug substance, Drug product | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022253-004 | RE38551 | 2022-03-17 | U-2140 | Drug substance, Drug product | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022253-004 | RE38551 | 2022-03-17 | U-1567 | Drug substance, Drug product | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022253-004 | RE38551 | 2022-03-17 | U-2999 | Drug substance, Drug product | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022253-004 | RE38551 | 2022-03-17 | U-2989 | Drug substance, Drug product | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022253-004 | RE38551 | 2022-03-17 | U-2990 | Drug substance, Drug product | 5d02ea3f76ae… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N022253-001 | D-188 | 2026-04-28 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022253-002 | D-188 | 2026-04-28 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022253-003 | D-188 | 2026-04-28 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022253-004 | D-188 | 2026-04-28 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022253-001 | D-188 | 2026-04-28 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022253-002 | D-188 | 2026-04-28 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022253-003 | D-188 | 2026-04-28 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022253-004 | D-188 | 2026-04-28 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022253-001 | D-188 | 2026-04-28 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022253-002 | D-188 | 2026-04-28 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022253-003 | D-188 | 2026-04-28 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022253-004 | D-188 | 2026-04-28 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022253-001 | D-188 | 2026-04-28 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022253-002 | D-188 | 2026-04-28 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022253-003 | D-188 | 2026-04-28 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022253-004 | D-188 | 2026-04-28 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022253-001 | D-188 | 2026-04-28 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022253-002 | D-188 | 2026-04-28 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022253-003 | D-188 | 2026-04-28 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022253-004 | D-188 | 2026-04-28 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022253-001 | NPP | 2024-10-14 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022253-001 | D-188 | 2026-04-28 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022253-002 | NPP | 2024-10-14 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022253-002 | D-188 | 2026-04-28 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022253-003 | NPP | 2024-10-14 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022253-003 | D-188 | 2026-04-28 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022253-004 | NPP | 2024-10-14 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022253-004 | D-188 | 2026-04-28 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022253-001 | NPP | 2024-10-14 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022253-001 | D-188 | 2026-04-28 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022253-002 | NPP | 2024-10-14 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022253-002 | D-188 | 2026-04-28 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022253-003 | NPP | 2024-10-14 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022253-003 | D-188 | 2026-04-28 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022253-004 | NPP | 2024-10-14 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022253-004 | D-188 | 2026-04-28 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022253-001 | NPP | 2024-10-14 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022253-001 | D-188 | 2026-04-28 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022253-002 | NPP | 2024-10-14 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022253-002 | D-188 | 2026-04-28 | 5bbf6a4d5a75… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Vimpat
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LACOSAMIDE | 50 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 563KS2PQY5 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 809974 | Internal RxNorm lookup |
| 809984 | Internal RxNorm lookup |
| 809987 | Internal RxNorm lookup |
| 809990 | Internal RxNorm lookup |
| 809992 | Internal RxNorm lookup |
| 809994 | Internal RxNorm lookup |
| 809996 | Internal RxNorm lookup |
| 809998 | Internal RxNorm lookup |
| 810000 | Internal RxNorm lookup |
| 810002 | Internal RxNorm lookup |
| 993856 | Internal RxNorm lookup |
| 995156 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9e79b42c-38a3-4b2c-a196-a5a1948250e2 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fac83aa9-21ef-4152-b501-369c0bc4765b | Product name | 1 | 20231010 |
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| 351abe41-466c-4dd8-840a-0fdb68318bd5 | Product name | 1 | 20230316 |
| c8c500b5-16db-e0e3-fdf1-c683d7be70e3 | Product name | 3 | 20161117 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0131-2477-35 | Vimpat | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | 63 | |
| 0131-2477-60 | Vimpat | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | 63 | |
| 0131-2477-60 | Vimpat | 6 in 1 CARTON | TABLET, FILM COATED | 6 | 63 | |
| 0131-2477-99 | Vimpat | 14 in 1 BLISTER PACK | TABLET, FILM COATED | 14 | 63 | |
| 0131-2477-99 | Vimpat | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 63 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0131-2477-35 | EA - Each | 0131-2477 | 40718446-b151-4118-8bbb-0f0e6868bf17 | 1 | 2012-07-24 |
| 0131-2477-60 | EA - Each | 0131-2477 | 677f86b1-3ec8-411e-a46e-2c4cfc6b11df | 1 | 2013-02-13 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0131-2477 | VIMPAT (LACOSAMIDE) TABLET, FILM COATED VIMPAT (LACOSAMIDE) INJECTION VIMPAT (LACOSAMIDE) SOLUTION [UCB, INC.] | 59 | Current NDC, Legacy NDC, 5 package rows | 20240925_9e79b42c-38a3-4b2c-a196-a5a1948250e2.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 |
|---|---|---|---|---|---|---|
| Vimpat | LACOSAMIDE | UCB, Inc. | 9e79b42c-38a3-4b2c-a196-a5a1948250e2 | 2026-05-12 | Warnings, Adverse reactions | 022253 NDA022253 0131-2477 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0131-2477-35 | 00131247735 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0131-2477-35) | 2009-05-26 | 0000-00-00 | No | No | Current | |
| 0131-2477-60 | 00131247760 | 6 BLISTER PACK in 1 CARTON (0131-2477-60) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 6 blister pack | 2009-05-26 | 0000-00-00 | No | No | Current |
| 0131-2477-99 | 00131247799 | 1 BLISTER PACK in 1 CARTON (0131-2477-99) / 14 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2009-05-26 | 0000-00-00 | No | No | Current |