Lamotrigine
- Product NDC
- 59746-246
- Requested package NDC
- 59746-246-01
- 11-digit product format
- 597460246
- Labeler code
- 59746
- Product ID
- 59746-246_1190d6b5-619e-46f0-aa54-7727eb4b183a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Jubilant Cadista Pharmacuticals Inc.
- Application
- ANDA079132
- Marketing category
- ANDA
- Marketing start
- 2009-01-27
- Substance
- LAMOTRIGINE
- Active strength
- 100 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A079132-001 | LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET / ORAL | AB | 2009-01-27 | |
| A079132-002 | LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET / ORAL | AB | 2009-01-27 | |
| A079132-003 | LAMOTRIGINE | LAMOTRIGINE | 150MG | TABLET / ORAL | AB | 2009-01-27 | |
| A079132-004 | LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET / ORAL | AB | 2009-01-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A079132-001 | AB |
| A079132-002 | AB |
| A079132-003 | AB |
| A079132-004 | 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 | A079132-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | AB | 2009-01-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A079132-002 | LAMOTRIGINE | 100MG | TABLET / ORAL | AB | 2009-01-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A079132-003 | LAMOTRIGINE | 150MG | TABLET / ORAL | AB | 2009-01-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A079132-004 | LAMOTRIGINE | 200MG | TABLET / ORAL | AB | 2009-01-27 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A079132-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | AB | 2009-01-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A079132-002 | LAMOTRIGINE | 100MG | TABLET / ORAL | AB | 2009-01-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A079132-003 | LAMOTRIGINE | 150MG | TABLET / ORAL | AB | 2009-01-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A079132-004 | LAMOTRIGINE | 200MG | TABLET / ORAL | AB | 2009-01-27 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A079132-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | AB | 2009-01-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A079132-002 | LAMOTRIGINE | 100MG | TABLET / ORAL | AB | 2009-01-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A079132-003 | LAMOTRIGINE | 150MG | TABLET / ORAL | AB | 2009-01-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A079132-004 | LAMOTRIGINE | 200MG | TABLET / ORAL | AB | 2009-01-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079132-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | AB | 2009-01-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079132-002 | LAMOTRIGINE | 100MG | TABLET / ORAL | AB | 2009-01-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079132-003 | LAMOTRIGINE | 150MG | TABLET / ORAL | AB | 2009-01-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079132-004 | LAMOTRIGINE | 200MG | TABLET / ORAL | AB | 2009-01-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A079132-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | AB | 2009-01-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A079132-002 | LAMOTRIGINE | 100MG | TABLET / ORAL | AB | 2009-01-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A079132-003 | LAMOTRIGINE | 150MG | TABLET / ORAL | AB | 2009-01-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A079132-004 | LAMOTRIGINE | 200MG | TABLET / ORAL | AB | 2009-01-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079132-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | AB | 2009-01-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079132-002 | LAMOTRIGINE | 100MG | TABLET / ORAL | AB | 2009-01-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079132-003 | LAMOTRIGINE | 150MG | TABLET / ORAL | AB | 2009-01-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079132-004 | LAMOTRIGINE | 200MG | TABLET / ORAL | AB | 2009-01-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079132-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | AB | 2009-01-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079132-002 | LAMOTRIGINE | 100MG | TABLET / ORAL | AB | 2009-01-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079132-003 | LAMOTRIGINE | 150MG | TABLET / ORAL | AB | 2009-01-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079132-004 | LAMOTRIGINE | 200MG | TABLET / ORAL | AB | 2009-01-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079132-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | AB | 2009-01-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079132-002 | LAMOTRIGINE | 100MG | TABLET / ORAL | AB | 2009-01-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079132-003 | LAMOTRIGINE | 150MG | TABLET / ORAL | AB | 2009-01-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079132-004 | LAMOTRIGINE | 200MG | TABLET / ORAL | AB | 2009-01-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079132-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | AB | 2009-01-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079132-002 | LAMOTRIGINE | 100MG | TABLET / ORAL | AB | 2009-01-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079132-003 | LAMOTRIGINE | 150MG | TABLET / ORAL | AB | 2009-01-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079132-004 | LAMOTRIGINE | 200MG | TABLET / ORAL | AB | 2009-01-27 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079132-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | AB | 2009-01-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079132-002 | LAMOTRIGINE | 100MG | TABLET / ORAL | AB | 2009-01-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079132-003 | LAMOTRIGINE | 150MG | TABLET / ORAL | AB | 2009-01-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079132-004 | LAMOTRIGINE | 200MG | TABLET / ORAL | AB | 2009-01-27 | 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 | A079132-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A079132-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A079132-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A079132-004 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A079132-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A079132-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A079132-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A079132-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A079132-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A079132-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A079132-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A079132-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079132-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079132-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079132-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079132-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A079132-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A079132-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A079132-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A079132-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079132-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079132-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079132-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079132-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079132-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079132-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079132-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079132-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079132-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079132-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079132-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079132-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079132-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079132-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079132-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079132-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079132-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079132-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079132-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079132-004 | 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
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LAMOTRIGINE | 100 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| U3H27498KS | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0b0f0209-edbd-46f3-9bed-762cbea0d737 | 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59746-246-01 | Lamotrigine | 100 in 1 BOTTLE | TABLET | 100 | 23 | |
| 59746-246-10 | Lamotrigine | 1000 in 1 BOTTLE | TABLET | 1000 | 23 | |
| 59746-246-90 | Lamotrigine | 90 in 1 BOTTLE | TABLET | 90 | 23 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 59746-246-01 | EA - Each | 59746-246 | 8840eac0-25bb-4eb4-93aa-5f017fe05fb2 | 1 | 2012-07-24 |
| 59746-246-10 | EA - Each | 59746-246 | 68c1c72a-2134-414f-999d-bf0e3866492c | 1 | 2012-07-24 |
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 | AvKARE | fcdb94a8-33be-6375-98ef-6933999d157f | 2026-05-13 | Boxed warning, Warnings, Adverse reactions | 079132 ANDA079132 |
| Lamotrigine | LAMOTRIGINE | Bryant Ranch Prepack | d33c4293-347c-49a1-9d98-f291c3dab6da | 2025-09-04 | Boxed warning, Warnings, Adverse reactions | 079132 ANDA079132 |
| Lamotrigine | LAMOTRIGINE | Jubilant Cadista Pharmacuticals Inc. | 0b0f0209-edbd-46f3-9bed-762cbea0d737 | 2025-07-15 | Boxed warning, Warnings, Adverse reactions | 079132 ANDA079132 59746-246-01 59746-246 59746024601 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 59746-246-01 | 59746024601 | 100 TABLET in 1 BOTTLE (59746-246-01) | 100 tablet | 2009-01-27 | 0000-00-00 | No | No | Current |