Lamotrigine
- Product NDC
- 49884-880
- 11-digit product format
- 498840880
- Labeler code
- 49884
- Product ID
- 49884-880_983458ba-0e97-42af-952c-3662407dde00
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- KIT
- Labeler
- Par Health USA, LLC
- Application
- ANDA204158
- Marketing category
- ANDA
- Marketing start
- 2015-11-27
- 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 |
|---|---|---|---|---|---|---|---|
| A204158-001 | LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-10-27 | |
| A204158-002 | LAMOTRIGINE | LAMOTRIGINE | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-10-27 | |
| A204158-003 | LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-10-27 | |
| A204158-004 | LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-10-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A204158-001 | AB |
| A204158-002 | AB |
| A204158-003 | AB |
| A204158-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A204158-001 | LAMOTRIGINE | 25MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-10-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A204158-002 | LAMOTRIGINE | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-10-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A204158-003 | LAMOTRIGINE | 100MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-10-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A204158-004 | LAMOTRIGINE | 200MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-10-27 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A204158-001 | LAMOTRIGINE | 25MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-10-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A204158-002 | LAMOTRIGINE | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-10-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A204158-003 | LAMOTRIGINE | 100MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-10-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A204158-004 | LAMOTRIGINE | 200MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-10-27 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204158-001 | LAMOTRIGINE | 25MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-10-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204158-002 | LAMOTRIGINE | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-10-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204158-003 | LAMOTRIGINE | 100MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-10-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204158-004 | LAMOTRIGINE | 200MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-10-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204158-001 | LAMOTRIGINE | 25MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-10-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204158-002 | LAMOTRIGINE | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-10-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204158-003 | LAMOTRIGINE | 100MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-10-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204158-004 | LAMOTRIGINE | 200MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-10-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204158-001 | LAMOTRIGINE | 25MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-10-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204158-002 | LAMOTRIGINE | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-10-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204158-003 | LAMOTRIGINE | 100MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-10-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204158-004 | LAMOTRIGINE | 200MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-10-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204158-001 | LAMOTRIGINE | 25MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-10-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204158-002 | LAMOTRIGINE | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-10-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204158-003 | LAMOTRIGINE | 100MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-10-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204158-004 | LAMOTRIGINE | 200MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-10-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204158-001 | LAMOTRIGINE | 25MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-10-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204158-002 | LAMOTRIGINE | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-10-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204158-003 | LAMOTRIGINE | 100MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-10-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204158-004 | LAMOTRIGINE | 200MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-10-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204158-001 | LAMOTRIGINE | 25MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-10-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204158-002 | LAMOTRIGINE | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-10-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204158-003 | LAMOTRIGINE | 100MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-10-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204158-004 | LAMOTRIGINE | 200MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-10-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204158-001 | LAMOTRIGINE | 25MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-10-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204158-002 | LAMOTRIGINE | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-10-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204158-003 | LAMOTRIGINE | 100MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-10-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204158-004 | LAMOTRIGINE | 200MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-10-27 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204158-001 | LAMOTRIGINE | 25MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-10-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204158-002 | LAMOTRIGINE | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-10-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204158-003 | LAMOTRIGINE | 100MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-10-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204158-004 | LAMOTRIGINE | 200MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-10-27 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A204158-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A204158-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A204158-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A204158-004 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A204158-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204158-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204158-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204158-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A204158-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204158-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204158-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204158-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204158-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204158-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204158-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204158-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A204158-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204158-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204158-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204158-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204158-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204158-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204158-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204158-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204158-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204158-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204158-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204158-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204158-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204158-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204158-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204158-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204158-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204158-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204158-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204158-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204158-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204158-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204158-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204158-004 | AB | 1 | 5bbf6a4d5a75… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lamotrigine
- Listing expiration
- 2027-12-31
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| U3H27498KS | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 003663e5-c0c7-4fc1-a64d-313f2a5b10d2 | 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 |
| a62a50ac-1535-4461-9768-8ae703e2e9fb | Product name | 1 | 20210525 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| bc07ef78-e82d-0c19-31f4-31f263780582 | Product name | 1 | 20140508 |
| e29d8e8b-4bc8-ebaf-f18e-e35287b19d6a | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49884-880-99 | Lamotrigine | 1 in 1 PACKAGE, COMBINATION | KIT | 1 | 45 | |
| 49884-880-99 | Lamotrigine | 1 in 1 BLISTER PACK | KIT | 1 | 45 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49884-880-99 | EA - Each | 49884-880 | be316477-9962-4eda-857e-254af29518a3 | 1 | 2016-01-13 |
DailyMed Socrata Ingredients#
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 | Par Health USA, LLC | 003663e5-c0c7-4fc1-a64d-313f2a5b10d2 | 2026-04-22 | Boxed warning, Warnings, Adverse reactions | 204158 ANDA204158 49884-880 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 851752 | {14 (lamotrigine 100 MG Disintegrating Oral Tablet) / 42 (lamotrigine 50 MG Disintegrating Oral Tablet) } Pack | GPCK | 003663e5-c0c7-4fc1-a64d-313f2a5b10d2 | 45 |
| 851748 | {21 (lamotrigine 25 MG Disintegrating Oral Tablet) / 7 (lamotrigine 50 MG Disintegrating Oral Tablet) } Pack | GPCK | 003663e5-c0c7-4fc1-a64d-313f2a5b10d2 | 45 |
| 851750 | {7 (lamotrigine 100 MG Disintegrating Oral Tablet) / 14 (lamotrigine 25 MG Disintegrating Oral Tablet) / 14 (lamotrigine 50 MG Disintegrating Oral Tablet) } Pack | GPCK | 003663e5-c0c7-4fc1-a64d-313f2a5b10d2 | 45 |
| 103968 | lamoTRIgine 100 MG Disintegrating Oral Tablet | PSN | 003663e5-c0c7-4fc1-a64d-313f2a5b10d2 | 45 |
| 252479 | lamoTRIgine 200 MG Disintegrating Oral Tablet | PSN | 003663e5-c0c7-4fc1-a64d-313f2a5b10d2 | 45 |
| 851750 | lamoTRIgine 25 MG (14), 50 MG (14), 100 MG (7) Disintegrating Oral Tablet 35 Count Pack | PSN | 003663e5-c0c7-4fc1-a64d-313f2a5b10d2 | 45 |
| 851748 | lamoTRIgine 25 MG (21), 50 MG (7) Disintegrating Oral Tablet 28 Count Pack | PSN | 003663e5-c0c7-4fc1-a64d-313f2a5b10d2 | 45 |
| 198430 | lamoTRIgine 25 MG Disintegrating Oral Tablet | PSN | 003663e5-c0c7-4fc1-a64d-313f2a5b10d2 | 45 |
| 851752 | lamoTRIgine 50 MG (42), 100 MG (14) Disintegrating Oral Tablet 56 Count Pack | PSN | 003663e5-c0c7-4fc1-a64d-313f2a5b10d2 | 45 |
| 252478 | lamoTRIgine 50 MG Disintegrating Oral Tablet | PSN | 003663e5-c0c7-4fc1-a64d-313f2a5b10d2 | 45 |
| 103968 | lamotrigine 100 MG Disintegrating Oral Tablet | SCD | 003663e5-c0c7-4fc1-a64d-313f2a5b10d2 | 45 |
| 252479 | lamotrigine 200 MG Disintegrating Oral Tablet | SCD | 003663e5-c0c7-4fc1-a64d-313f2a5b10d2 | 45 |
| 198430 | lamotrigine 25 MG Disintegrating Oral Tablet | SCD | 003663e5-c0c7-4fc1-a64d-313f2a5b10d2 | 45 |
| 252478 | lamotrigine 50 MG Disintegrating Oral Tablet | SCD | 003663e5-c0c7-4fc1-a64d-313f2a5b10d2 | 45 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 49884-880-99 | 49884088099 | 1 BLISTER PACK in 1 PACKAGE, COMBINATION (49884-880-99) / 1 KIT in 1 BLISTER PACK | 1 blister pack | 2015-12-16 | 0000-00-00 | No | No | Current |