Lamotrigine
- Product NDC
- 13668-339
- 11-digit product format
- 136680339
- Labeler code
- 13668
- Product ID
- 13668-339_aae9e98a-c9b3-4e3c-8e24-ff46f11bcadf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Torrent Pharmaceuticals Limited
- Application
- ANDA203370
- Marketing category
- ANDA
- Marketing start
- 2013-12-23
- 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
- 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 |
|---|---|---|---|---|---|---|---|
| A203370-001 | LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-12-23 | |
| A203370-002 | LAMOTRIGINE | LAMOTRIGINE | 50MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-12-23 | |
| A203370-003 | LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-12-23 | |
| A203370-004 | LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2013-12-23 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A203370-001 | AB |
| A203370-002 | AB |
| A203370-003 | 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 | A203370-001 | LAMOTRIGINE | 25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-12-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203370-002 | LAMOTRIGINE | 50MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-12-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203370-003 | LAMOTRIGINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-12-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203370-004 | LAMOTRIGINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2013-12-23 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203370-001 | LAMOTRIGINE | 25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-12-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203370-002 | LAMOTRIGINE | 50MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-12-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203370-003 | LAMOTRIGINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-12-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203370-004 | LAMOTRIGINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2013-12-23 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A203370-001 | LAMOTRIGINE | 25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-12-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203370-002 | LAMOTRIGINE | 50MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-12-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203370-003 | LAMOTRIGINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-12-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203370-004 | LAMOTRIGINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2013-12-23 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203370-001 | LAMOTRIGINE | 25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-12-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203370-002 | LAMOTRIGINE | 50MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-12-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203370-003 | LAMOTRIGINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-12-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203370-004 | LAMOTRIGINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2013-12-23 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203370-001 | LAMOTRIGINE | 25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-12-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203370-002 | LAMOTRIGINE | 50MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-12-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203370-003 | LAMOTRIGINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-12-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203370-004 | LAMOTRIGINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2013-12-23 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203370-001 | LAMOTRIGINE | 25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-12-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203370-002 | LAMOTRIGINE | 50MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-12-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203370-003 | LAMOTRIGINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-12-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203370-004 | LAMOTRIGINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2013-12-23 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203370-001 | LAMOTRIGINE | 25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-12-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203370-002 | LAMOTRIGINE | 50MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-12-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203370-003 | LAMOTRIGINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-12-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203370-004 | LAMOTRIGINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2013-12-23 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203370-001 | LAMOTRIGINE | 25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-12-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203370-002 | LAMOTRIGINE | 50MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-12-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203370-003 | LAMOTRIGINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-12-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203370-004 | LAMOTRIGINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2013-12-23 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203370-001 | LAMOTRIGINE | 25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-12-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203370-002 | LAMOTRIGINE | 50MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-12-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203370-003 | LAMOTRIGINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-12-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203370-004 | LAMOTRIGINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2013-12-23 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A203370-001 | LAMOTRIGINE | 25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-12-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203370-002 | LAMOTRIGINE | 50MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-12-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203370-003 | LAMOTRIGINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2013-12-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203370-004 | LAMOTRIGINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | 2013-12-23 | 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 | A203370-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203370-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203370-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203370-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203370-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203370-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A203370-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203370-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203370-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203370-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203370-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203370-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203370-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203370-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203370-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203370-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203370-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203370-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203370-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203370-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203370-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203370-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203370-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203370-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203370-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203370-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203370-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A203370-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A203370-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A203370-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203370-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203370-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203370-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203370-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203370-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203370-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203370-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203370-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203370-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A203370-001 | AB | 1 | 8072bd15b7f6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lamotrigine
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LAMOTRIGINE | 25 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| U3H27498KS | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 52df02a7-83da-4b20-9951-69790237dc24 | 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 |
| 351abe41-466c-4dd8-840a-0fdb68318bd5 | Product name | 1 | 20230316 |
| e29d8e8b-4bc8-ebaf-f18e-e35287b19d6a | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 13668-339-01 | Lamotrigine | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | 19 | |
| 13668-339-05 | Lamotrigine | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | 19 | |
| 13668-339-30 | Lamotrigine | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | 19 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 13668-339-30 | EA - Each | 13668-339 | 81f5737b-b203-4118-bb76-442d99301c03 | 1 | 2018-01-12 |
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 | REMEDYREPACK INC. | de7f61ca-e3c0-4a09-b664-0df2de6a0c30 | 2026-07-03 | Boxed warning, Warnings, Adverse reactions | 203370 ANDA203370 |
| Lamotrigine | LAMOTRIGINE | Torrent Pharmaceuticals Limited | 52df02a7-83da-4b20-9951-69790237dc24 | 2026-03-04 | Boxed warning, Warnings, Adverse reactions | 203370 ANDA203370 13668-339 |
| Lamotrigine | LAMOTRIGINE | Proficient Rx LP | ffa46cb2-16e7-45f3-9940-5cb88d0cda9d | 2024-05-01 | Boxed warning, Warnings, Adverse reactions | 203370 ANDA203370 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 850087 | lamoTRIgine 100 MG 24HR Extended Release Oral Tablet | PSN | 52df02a7-83da-4b20-9951-69790237dc24 | 19 |
| 900156 | lamoTRIgine 200 MG 24HR Extended Release Oral Tablet | PSN | 52df02a7-83da-4b20-9951-69790237dc24 | 19 |
| 900164 | lamoTRIgine 25 MG 24HR Extended Release Oral Tablet | PSN | 52df02a7-83da-4b20-9951-69790237dc24 | 19 |
| 850091 | lamoTRIgine 50 MG 24HR Extended Release Oral Tablet | PSN | 52df02a7-83da-4b20-9951-69790237dc24 | 19 |
| 850087 | 24 HR lamotrigine 100 MG Extended Release Oral Tablet | SCD | 52df02a7-83da-4b20-9951-69790237dc24 | 19 |
| 900156 | 24 HR lamotrigine 200 MG Extended Release Oral Tablet | SCD | 52df02a7-83da-4b20-9951-69790237dc24 | 19 |
| 900164 | 24 HR lamotrigine 25 MG Extended Release Oral Tablet | SCD | 52df02a7-83da-4b20-9951-69790237dc24 | 19 |
| 850091 | 24 HR lamotrigine 50 MG Extended Release Oral Tablet | SCD | 52df02a7-83da-4b20-9951-69790237dc24 | 19 |
| 850087 | lamotrigine 100 MG 24 HR Extended Release Oral Tablet | SY | 52df02a7-83da-4b20-9951-69790237dc24 | 19 |
| 900156 | lamotrigine 200 MG 24 HR Extended Release Oral Tablet | SY | 52df02a7-83da-4b20-9951-69790237dc24 | 19 |
| 900164 | lamotrigine 25 MG 24 HR Extended Release Oral Tablet | SY | 52df02a7-83da-4b20-9951-69790237dc24 | 19 |
| 850091 | lamotrigine 50 MG 24 HR Extended Release Oral Tablet | SY | 52df02a7-83da-4b20-9951-69790237dc24 | 19 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 13668-339-01 | 13668033901 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-339-01) | 2013-12-23 | 0000-00-00 | No | No | Current |
| 13668-339-05 | 13668033905 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-339-05) | 2013-12-23 | 0000-00-00 | No | No | Current |
| 13668-339-30 | 13668033930 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-339-30) | 2013-12-23 | 0000-00-00 | No | No | Current |
| 13668-339-74 | 13668033974 | 100 TABLET, EXTENDED RELEASE in 1 CARTON (13668-339-74) | 2013-12-23 | 0000-00-00 | No | No | Current |