Lamotrigine
- Product NDC
- 55700-683
- 11-digit product format
- 557000683
- Labeler code
- 55700
- Product ID
- 55700-683_45ada93f-ca8e-4bc9-8737-e81044f60d3b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lake Erie Medical DBA Quality Care Products LLC
- Application
- ANDA090170
- Marketing category
- ANDA
- Marketing start
- 2018-09-14
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- 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 | 55700-683 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 55700-683 | 55700-683-30 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 55700-683 | 55700-683-60 | D | Discontinued by firm | 2026-08-03 |
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 | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 55700-683-60 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 55700-683-30 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 55700-683-60 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 55700-683-30 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 55700-683-60 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 55700-683-30 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 55700-683-60 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 55700-683-30 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 55700-683-60 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 55700-683-30 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 55700-683-60 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 55700-683-30 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 55700-683-60 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 55700-683-30 | 302b2466d912… | e7b80fea0513… |
| 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 | 55700-683-60 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 55700-683-30 | 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 | 55700-683-60 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 55700-683-30 | 0efc9e666f02… | f202fb6c5f17… |
Orange Book products#
| 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#
| Application-product | TE code |
|---|---|
| A090170-001 | AB |
| A090170-002 | AB |
| A090170-003 | AB |
| A090170-004 | 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 | 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… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090170-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | AB | 2011-10-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090170-002 | LAMOTRIGINE | 100MG | TABLET / ORAL | AB | 2011-10-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090170-003 | LAMOTRIGINE | 150MG | TABLET / ORAL | AB | 2011-10-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090170-004 | LAMOTRIGINE | 200MG | TABLET / ORAL | AB | 2011-10-06 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090170-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | AB | 2011-10-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090170-002 | LAMOTRIGINE | 100MG | TABLET / ORAL | AB | 2011-10-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090170-003 | LAMOTRIGINE | 150MG | TABLET / ORAL | AB | 2011-10-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090170-004 | LAMOTRIGINE | 200MG | TABLET / ORAL | AB | 2011-10-06 | 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 | A090170-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090170-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090170-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090170-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090170-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090170-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090170-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090170-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090170-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090170-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090170-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090170-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090170-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090170-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090170-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090170-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090170-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090170-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090170-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090170-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090170-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090170-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090170-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090170-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090170-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090170-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090170-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090170-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090170-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090170-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090170-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090170-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090170-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090170-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090170-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090170-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090170-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090170-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090170-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090170-004 | AB | 1 | d06236e962d9… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55700-683-30 | EA - Each | 55700-683 | 8559d714-7c83-4d80-8716-9e016dd7b313 | 1 | 2018-10-11 |
| 55700-683-60 | EA - Each | 55700-683 | 849d7138-26b5-4a6f-951f-bc6ebee6b3b6 | 1 | 2018-10-11 |
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 |
|---|---|---|---|---|---|---|
| Lamotrigine | LAMOTRIGINE | REMEDYREPACK INC. | d1691a60-ff0a-4755-b445-1d78309d5af0 | 2026-07-27 | Boxed warning, Warnings, Adverse reactions | 090170 ANDA090170 |
| Lamotrigine | LAMOTRIGINE | REMEDYREPACK INC. | 346f8af3-b850-48e4-bd6e-82ecafca86d2 | 2026-07-23 | Boxed warning, Warnings, Adverse reactions | 090170 ANDA090170 |
| Lamotrigine | LAMOTRIGINE | REMEDYREPACK INC. | f5761818-4eaf-4335-a77a-9cd703278ded | 2026-07-22 | Boxed warning, Warnings, Adverse reactions | 090170 ANDA090170 |
| Lamotrigine | LAMOTRIGINE | REMEDYREPACK INC. | 1b5646a9-4724-44b8-8cd0-9c14f5e87f86 | 2026-07-16 | Boxed warning, Warnings, Adverse reactions | 090170 ANDA090170 |
| Lamotrigine | LAMOTRIGINE | Coupler LLC | 55f41c7e-03a6-b84c-e063-6294a90a7d82 | 2026-07-06 | Boxed warning, Warnings, Adverse reactions | 090170 ANDA090170 |
| Lamotrigine | LAMOTRIGINE | REMEDYREPACK INC. | 3ed4590d-71e3-4208-b6c0-98330acc7b85 | 2026-07-06 | Boxed warning, Warnings, Adverse reactions | 090170 ANDA090170 |
| Lamotrigine | LAMOTRIGINE | Coupler LLC | 545fcc0e-1e2b-bdcb-e063-6294a90a4ac7 | 2026-06-16 | Boxed warning, Warnings, Adverse reactions | 090170 ANDA090170 |
| Lamotrigine | LAMOTRIGINE | Bryant Ranch Prepack | b1601109-5c17-4482-9257-1e0be7546e8f | 2026-06-11 | Boxed warning, Warnings, Adverse reactions | 090170 ANDA090170 |
| Lamotrigine | LAMOTRIGINE | Coupler LLC | 52b8be5c-ef88-dfa7-e063-6394a90a0500 | 2026-05-26 | Boxed warning, Warnings, Adverse reactions | 090170 ANDA090170 |
| Lamotrigine | LAMOTRIGINE | Unichem Pharmaceuticals (USA), Inc. | 4b72ea7a-a0b0-4980-84ad-84f64e2e6368 | 2026-05-19 | Boxed warning, Warnings, Adverse reactions | 090170 ANDA090170 |
| Lamotrigine | LAMOTRIGINE | Preferred Pharmaceuticals, Inc. | 16323699-9bf8-43c7-b3aa-589156377872 | 2026-05-18 | Boxed warning, Warnings, Adverse reactions | 090170 ANDA090170 |
| Lamotrigine | LAMOTRIGINE | Preferred Pharmaceuticals Inc. | 09a0d30d-9b8f-4c76-8cdb-8492386b2254 | 2026-05-18 | Boxed warning, Warnings, Adverse reactions | 090170 ANDA090170 |
| Lamotrigine | LAMOTRIGINE | A-S Medication Solutions | 6139a858-700c-4eb9-9f84-99d280bde326 | 2026-03-02 | Boxed warning, Warnings, Adverse reactions | 090170 ANDA090170 |
| Lamotrigine | LAMOTRIGINE | PD-Rx Pharmaceuticals, Inc. | dc6e6735-d49a-44d8-936d-7c33437bc59e | 2026-02-17 | Boxed warning, Warnings, Adverse reactions | 090170 ANDA090170 |
| Lamotrigine | LAMOTRIGINE | REMEDYREPACK INC. | 811188be-d231-4b58-8d7a-b01b236fab51 | 2026-01-29 | Boxed warning, Warnings, Adverse reactions | 090170 ANDA090170 |
| Lamotrigine | LAMOTRIGINE | Northwind Health Company, LLC | db5f7ee5-9bd9-1819-e053-2a95a90a91df | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 090170 ANDA090170 |
| Lamotrigine | LAMOTRIGINE | A-S Medication Solutions | 84277e2c-370c-4510-92bc-ef33a4a0f508 | 2025-12-05 | Boxed warning, Warnings, Adverse reactions | 090170 ANDA090170 |
| Lamotrigine | LAMOTRIGINE | Bryant Ranch Prepack | 8e1e4fa8-881c-4618-88f6-018ab15db44d | 2025-09-18 | Boxed warning, Warnings, Adverse reactions | 090170 ANDA090170 |
| Lamotrigine | LAMOTRIGINE | Bryant Ranch Prepack | 812bc0d8-bb31-4fb1-9f4a-f8c17cbc769c | 2025-09-17 | Boxed warning, Warnings, Adverse reactions | 090170 ANDA090170 |
| Lamotrigine | LAMOTRIGINE | Bryant Ranch Prepack | 53774022-ea0c-42a9-a720-dc755c77b851 | 2025-09-17 | Boxed warning, Warnings, Adverse reactions | 090170 ANDA090170 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55700-683-30 | 55700068330 | 30 TABLET in 1 BOTTLE, PLASTIC (55700-683-30) | 30 tablet | 2018-09-14 | 0000-00-00 | No | No | Current |
| 55700-683-60 | 55700068360 | 60 TABLET in 1 BOTTLE, PLASTIC (55700-683-60) | 60 tablet | 2018-09-14 | 0000-00-00 | No | No | Current |