Lacosamide
- Product NDC
- 67877-733
- 11-digit product format
- 678770733
- Labeler code
- 67877
- Product ID
- 67877-733_062a789f-52f0-482b-9ec0-2ba3ac1572ec
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lacosamide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Ascend Laboratories, LLC
- Application
- ANDA214695
- Marketing category
- ANDA
- Marketing start
- 2022-04-01
- 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
- 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 |
|---|---|---|---|---|---|---|---|
| A214695-001 | LACOSAMIDE | LACOSAMIDE | 50MG | TABLET / ORAL | AB | 2022-03-31 | |
| A214695-002 | LACOSAMIDE | LACOSAMIDE | 100MG | TABLET / ORAL | AB | 2022-03-31 | |
| A214695-003 | LACOSAMIDE | LACOSAMIDE | 150MG | TABLET / ORAL | AB | 2022-03-31 | |
| A214695-004 | LACOSAMIDE | LACOSAMIDE | 200MG | TABLET / ORAL | AB | 2022-03-31 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A214695-001 | AB |
| A214695-002 | AB |
| A214695-003 | AB |
| A214695-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A214695-001 | LACOSAMIDE | 50MG | TABLET / ORAL | AB | 2022-03-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A214695-002 | LACOSAMIDE | 100MG | TABLET / ORAL | AB | 2022-03-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A214695-003 | LACOSAMIDE | 150MG | TABLET / ORAL | AB | 2022-03-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A214695-004 | LACOSAMIDE | 200MG | TABLET / ORAL | AB | 2022-03-31 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A214695-001 | LACOSAMIDE | 50MG | TABLET / ORAL | AB | 2022-03-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A214695-002 | LACOSAMIDE | 100MG | TABLET / ORAL | AB | 2022-03-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A214695-003 | LACOSAMIDE | 150MG | TABLET / ORAL | AB | 2022-03-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A214695-004 | LACOSAMIDE | 200MG | TABLET / ORAL | AB | 2022-03-31 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214695-001 | LACOSAMIDE | 50MG | TABLET / ORAL | AB | 2022-03-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214695-002 | LACOSAMIDE | 100MG | TABLET / ORAL | AB | 2022-03-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214695-003 | LACOSAMIDE | 150MG | TABLET / ORAL | AB | 2022-03-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214695-004 | LACOSAMIDE | 200MG | TABLET / ORAL | AB | 2022-03-31 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A214695-001 | LACOSAMIDE | 50MG | TABLET / ORAL | AB | 2022-03-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A214695-002 | LACOSAMIDE | 100MG | TABLET / ORAL | AB | 2022-03-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A214695-003 | LACOSAMIDE | 150MG | TABLET / ORAL | AB | 2022-03-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A214695-004 | LACOSAMIDE | 200MG | TABLET / ORAL | AB | 2022-03-31 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214695-001 | LACOSAMIDE | 50MG | TABLET / ORAL | AB | 2022-03-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214695-002 | LACOSAMIDE | 100MG | TABLET / ORAL | AB | 2022-03-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214695-003 | LACOSAMIDE | 150MG | TABLET / ORAL | AB | 2022-03-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214695-004 | LACOSAMIDE | 200MG | TABLET / ORAL | AB | 2022-03-31 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214695-001 | LACOSAMIDE | 50MG | TABLET / ORAL | AB | 2022-03-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214695-002 | LACOSAMIDE | 100MG | TABLET / ORAL | AB | 2022-03-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214695-003 | LACOSAMIDE | 150MG | TABLET / ORAL | AB | 2022-03-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214695-004 | LACOSAMIDE | 200MG | TABLET / ORAL | AB | 2022-03-31 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214695-001 | LACOSAMIDE | 50MG | TABLET / ORAL | AB | 2022-03-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214695-002 | LACOSAMIDE | 100MG | TABLET / ORAL | AB | 2022-03-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214695-003 | LACOSAMIDE | 150MG | TABLET / ORAL | AB | 2022-03-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214695-004 | LACOSAMIDE | 200MG | TABLET / ORAL | AB | 2022-03-31 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214695-001 | LACOSAMIDE | 50MG | TABLET / ORAL | AB | 2022-03-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214695-002 | LACOSAMIDE | 100MG | TABLET / ORAL | AB | 2022-03-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214695-003 | LACOSAMIDE | 150MG | TABLET / ORAL | AB | 2022-03-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214695-004 | LACOSAMIDE | 200MG | TABLET / ORAL | AB | 2022-03-31 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214695-001 | LACOSAMIDE | 50MG | TABLET / ORAL | AB | 2022-03-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214695-002 | LACOSAMIDE | 100MG | TABLET / ORAL | AB | 2022-03-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214695-003 | LACOSAMIDE | 150MG | TABLET / ORAL | AB | 2022-03-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214695-004 | LACOSAMIDE | 200MG | TABLET / ORAL | AB | 2022-03-31 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214695-001 | LACOSAMIDE | 50MG | TABLET / ORAL | AB | 2022-03-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214695-002 | LACOSAMIDE | 100MG | TABLET / ORAL | AB | 2022-03-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214695-003 | LACOSAMIDE | 150MG | TABLET / ORAL | AB | 2022-03-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214695-004 | LACOSAMIDE | 200MG | TABLET / ORAL | AB | 2022-03-31 | d8e5a09893c0… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A214695-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A214695-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A214695-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A214695-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A214695-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A214695-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A214695-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A214695-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214695-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214695-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214695-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214695-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A214695-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A214695-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A214695-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A214695-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214695-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214695-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214695-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214695-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214695-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214695-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214695-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214695-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214695-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214695-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214695-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214695-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214695-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214695-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214695-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214695-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214695-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214695-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214695-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214695-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214695-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214695-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214695-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214695-004 | AB | 1 | d8e5a09893c0… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lacosamide
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LACOSAMIDE | 50 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 563KS2PQY5 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9d7fde23-dc3f-41e9-89cf-6a1a9eeaa7de | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 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 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| c8c500b5-16db-e0e3-fdf1-c683d7be70e3 | Product name | 3 | 20161117 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67877-733-05 | Lacosamide | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | 19 | |
| 67877-733-31 | Lacosamide | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | 19 | |
| 67877-733-31 | Lacosamide | 6 in 1 CARTON | TABLET, FILM COATED | 6 | 19 | |
| 67877-733-60 | Lacosamide | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | 19 | |
| 67877-733-90 | Lacosamide | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 19 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 67877-733-60 | EA - Each | 67877-733 | 6a50caf2-3902-4533-bd88-5ce474112d18 | 1 | 2022-05-04 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Lacosamide | LACOSAMIDE | REMEDYREPACK INC. | d823fbfa-8ff5-4ef8-84ce-fbe916d4e430 | 2026-07-07 | Warnings, Adverse reactions | 214695 ANDA214695 |
| Lacosamide | LACOSAMIDE | Major Pharmaceuticals | c83d2156-4dde-4316-98f1-b3dc751f3eac | 2026-06-09 | Warnings, Adverse reactions | 214695 ANDA214695 |
| Lacosamide | LACOSAMIDE | American Health Packaging | 19060029-c158-4a37-9261-cfe3b2b5b1e3 | 2026-03-06 | Warnings, Adverse reactions | 214695 ANDA214695 |
| Lacosamide | LACOSAMIDE | REMEDYREPACK INC. | 8d2906e3-d059-425d-b971-29423963c2af | 2026-02-03 | Warnings, Adverse reactions | 214695 ANDA214695 |
| Lacosamide | LACOSAMIDE | Ascend Laboratories, LLC | 9d7fde23-dc3f-41e9-89cf-6a1a9eeaa7de | 2025-08-11 | Warnings, Adverse reactions | 214695 ANDA214695 67877-733 |
| Lacosamide | LACOSAMIDE | Advanced Rx of Tennessee, LLC | 325df1b7-4908-0c03-e063-6294a90ad844 | 2025-04-09 | Warnings, Adverse reactions | 214695 ANDA214695 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 67877-733-05 | 67877073305 | 500 TABLET, FILM COATED in 1 BOTTLE (67877-733-05) | 2022-04-01 | 0000-00-00 | No | No | Current | |
| 67877-733-31 | 67877073331 | 6 BLISTER PACK in 1 CARTON (67877-733-31) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 6 blister pack | 2022-04-01 | 0000-00-00 | No | No | Current |
| 67877-733-60 | 67877073360 | 60 TABLET, FILM COATED in 1 BOTTLE (67877-733-60) | 2022-04-01 | 0000-00-00 | No | No | Current | |
| 67877-733-90 | 67877073390 | 90 TABLET, FILM COATED in 1 BOTTLE (67877-733-90) | 2022-04-01 | 0000-00-00 | No | No | Current |