Lamotrigine
- Product NDC
- 0115-9940
- Requested package NDC
- 0115-9940-08
- 11-digit product format
- 001159940
- Labeler code
- 0115
- Product ID
- 0115-9940_813e9f35-df9e-428a-9f4f-1a312c86f937
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LAMOTRIGINE
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- ANDA200828
- Marketing category
- ANDA
- Marketing start
- 2018-12-27
- Substance
- LAMOTRIGINE
- Active strength
- 50 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
- 2026-12-31
- Current FDA listing
- Yes
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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | 1332a3947898… | d4bfe170f9cd… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A200828-001 | LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-07-15 | |
| A200828-002 | LAMOTRIGINE | LAMOTRIGINE | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-07-15 | |
| A200828-003 | LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-07-15 | |
| A200828-004 | LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-07-15 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A200828-001 | AB |
| A200828-002 | AB |
| A200828-003 | AB |
| A200828-004 | 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 | A200828-001 | LAMOTRIGINE | 25MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-07-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A200828-002 | LAMOTRIGINE | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-07-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A200828-003 | LAMOTRIGINE | 100MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-07-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A200828-004 | LAMOTRIGINE | 200MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-07-15 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200828-001 | LAMOTRIGINE | 25MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-07-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200828-002 | LAMOTRIGINE | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-07-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200828-003 | LAMOTRIGINE | 100MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-07-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200828-004 | LAMOTRIGINE | 200MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-07-15 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A200828-001 | LAMOTRIGINE | 25MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-07-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A200828-002 | LAMOTRIGINE | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-07-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A200828-003 | LAMOTRIGINE | 100MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-07-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A200828-004 | LAMOTRIGINE | 200MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-07-15 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200828-001 | LAMOTRIGINE | 25MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-07-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200828-002 | LAMOTRIGINE | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-07-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200828-003 | LAMOTRIGINE | 100MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-07-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200828-004 | LAMOTRIGINE | 200MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-07-15 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200828-001 | LAMOTRIGINE | 25MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-07-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200828-002 | LAMOTRIGINE | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-07-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200828-003 | LAMOTRIGINE | 100MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-07-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200828-004 | LAMOTRIGINE | 200MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-07-15 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200828-001 | LAMOTRIGINE | 25MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-07-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200828-002 | LAMOTRIGINE | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-07-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200828-003 | LAMOTRIGINE | 100MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-07-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200828-004 | LAMOTRIGINE | 200MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-07-15 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200828-001 | LAMOTRIGINE | 25MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-07-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200828-002 | LAMOTRIGINE | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-07-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200828-003 | LAMOTRIGINE | 100MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-07-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200828-004 | LAMOTRIGINE | 200MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-07-15 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200828-001 | LAMOTRIGINE | 25MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2013-07-15 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200828-002 | LAMOTRIGINE | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2013-07-15 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200828-003 | LAMOTRIGINE | 100MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2013-07-15 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200828-004 | LAMOTRIGINE | 200MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2013-07-15 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200828-001 | LAMOTRIGINE | 25MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-07-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200828-002 | LAMOTRIGINE | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-07-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200828-003 | LAMOTRIGINE | 100MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-07-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200828-004 | LAMOTRIGINE | 200MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-07-15 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A200828-001 | LAMOTRIGINE | 25MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2013-07-15 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A200828-002 | LAMOTRIGINE | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2013-07-15 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A200828-003 | LAMOTRIGINE | 100MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2013-07-15 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A200828-004 | LAMOTRIGINE | 200MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2013-07-15 | 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 | A200828-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A200828-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A200828-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A200828-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200828-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200828-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200828-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200828-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A200828-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A200828-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A200828-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A200828-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200828-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200828-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200828-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200828-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200828-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200828-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200828-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200828-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200828-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200828-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200828-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200828-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200828-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200828-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200828-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200828-004 | AB | 1 | 2680178bc6a6… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200828-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200828-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200828-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200828-004 | AB | 1 | d8e5a09893c0… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A200828-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A200828-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A200828-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A200828-004 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A200828-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A200828-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A200828-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A200828-004 | AB | 1 | 5d02ea3f76ae… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lamotrigine
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LAMOTRIGINE | 50 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| U3H27498KS | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9e5c2d76-47a6-4a57-b23c-2398b307380c | 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 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0115-9940-01 | Lamotrigine | 30 in 1 BOTTLE | TABLET, ORALLY DISINTEGRATING | 30 | 14 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0115-9940-01 | EA - Each | 0115-9940 | 3db0dd87-ab92-41bc-957b-5e79d55a80ac | 1 | 2025-02-10 |
| 0115-9940-08 | EA - Each | 0115-9940 | 79061c35-9a03-4c11-a2e3-47617dab91a4 | 1 | 2019-05-02 |
| 0115-9940-68 | EA - Each | 0115-9940 | 06e88c61-69b4-4cdd-ba16-426fbc6fe480 | 1 | 2019-05-02 |
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 |
|---|---|---|---|---|---|---|
| Lamotrigine | LAMOTRIGINE | Amneal Pharmaceuticals of New York LLC | 9e5c2d76-47a6-4a57-b23c-2398b307380c | 2025-12-04 | Boxed warning, Warnings, Adverse reactions | 200828 ANDA200828 0115-9940 |
| Lamotrigine | LAMOTRIGINE | Amneal Pharmaceuticals of New York LLC | 380bddae-5b31-4965-96de-97711d859d11 | 2016-02-02 | Boxed warning, Warnings, Adverse reactions | 200828 ANDA200828 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 103968 | lamoTRIgine 100 MG Disintegrating Oral Tablet | PSN | 9e5c2d76-47a6-4a57-b23c-2398b307380c | 14 |
| 252479 | lamoTRIgine 200 MG Disintegrating Oral Tablet | PSN | 9e5c2d76-47a6-4a57-b23c-2398b307380c | 14 |
| 198430 | lamoTRIgine 25 MG Disintegrating Oral Tablet | PSN | 9e5c2d76-47a6-4a57-b23c-2398b307380c | 14 |
| 252478 | lamoTRIgine 50 MG Disintegrating Oral Tablet | PSN | 9e5c2d76-47a6-4a57-b23c-2398b307380c | 14 |
| 103968 | lamotrigine 100 MG Disintegrating Oral Tablet | SCD | 9e5c2d76-47a6-4a57-b23c-2398b307380c | 14 |
| 252479 | lamotrigine 200 MG Disintegrating Oral Tablet | SCD | 9e5c2d76-47a6-4a57-b23c-2398b307380c | 14 |
| 198430 | lamotrigine 25 MG Disintegrating Oral Tablet | SCD | 9e5c2d76-47a6-4a57-b23c-2398b307380c | 14 |
| 252478 | lamotrigine 50 MG Disintegrating Oral Tablet | SCD | 9e5c2d76-47a6-4a57-b23c-2398b307380c | 14 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0115-9940-08 | 00115994008 | 2 BLISTER PACK in 1 CARTON (0115-9940-08) > 15 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0115-9940-68) | 2 blister pack | 2018-12-27 | 0000-00-00 | No | No | Current |