Lamotrigine
- Product NDC
- 70518-4702
- Requested package NDC
- 70518-4702-0
- 11-digit product format
- 705184702
- Labeler code
- 70518
- Product ID
- 70518-4702_570a1f6b-080c-2ded-e063-6394a90a1152
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA207763
- Marketing category
- ANDA
- Marketing start
- 2026-07-19
- 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
- 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 |
|---|---|---|---|---|---|---|---|
| A207763-001 | LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-04-01 | |
| A207763-002 | LAMOTRIGINE | LAMOTRIGINE | 50MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-04-01 | |
| A207763-003 | LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-04-01 | |
| A207763-004 | LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-04-01 | |
| A207763-005 | LAMOTRIGINE | LAMOTRIGINE | 250MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-04-01 | |
| A207763-006 | LAMOTRIGINE | LAMOTRIGINE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-04-01 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A207763-001 | AB |
| A207763-002 | AB |
| A207763-003 | AB |
| A207763-004 | AB |
| A207763-005 | AB |
| A207763-006 | 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 | A207763-001 | LAMOTRIGINE | 25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-04-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A207763-002 | LAMOTRIGINE | 50MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-04-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A207763-003 | LAMOTRIGINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-04-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A207763-004 | LAMOTRIGINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-04-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A207763-005 | LAMOTRIGINE | 250MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-04-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A207763-006 | LAMOTRIGINE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-04-01 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A207763-001 | LAMOTRIGINE | 25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-04-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207763-002 | LAMOTRIGINE | 50MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-04-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207763-003 | LAMOTRIGINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-04-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207763-004 | LAMOTRIGINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-04-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207763-005 | LAMOTRIGINE | 250MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-04-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207763-006 | LAMOTRIGINE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-04-01 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207763-001 | LAMOTRIGINE | 25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-04-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207763-002 | LAMOTRIGINE | 50MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-04-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207763-003 | LAMOTRIGINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-04-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207763-004 | LAMOTRIGINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-04-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207763-005 | LAMOTRIGINE | 250MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-04-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207763-006 | LAMOTRIGINE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-04-01 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207763-001 | LAMOTRIGINE | 25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-04-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207763-002 | LAMOTRIGINE | 50MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-04-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207763-003 | LAMOTRIGINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-04-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207763-004 | LAMOTRIGINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-04-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207763-005 | LAMOTRIGINE | 250MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-04-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207763-006 | LAMOTRIGINE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-04-01 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207763-001 | LAMOTRIGINE | 25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-04-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207763-002 | LAMOTRIGINE | 50MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-04-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207763-003 | LAMOTRIGINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-04-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207763-004 | LAMOTRIGINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-04-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207763-005 | LAMOTRIGINE | 250MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-04-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207763-006 | LAMOTRIGINE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-04-01 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207763-001 | LAMOTRIGINE | 25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-04-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207763-002 | LAMOTRIGINE | 50MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-04-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207763-003 | LAMOTRIGINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-04-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207763-004 | LAMOTRIGINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-04-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207763-005 | LAMOTRIGINE | 250MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-04-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207763-006 | LAMOTRIGINE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-04-01 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207763-001 | LAMOTRIGINE | 25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-04-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207763-002 | LAMOTRIGINE | 50MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-04-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207763-003 | LAMOTRIGINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-04-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207763-004 | LAMOTRIGINE | 200MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-04-01 | b8a1b40f171c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A207763-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207763-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207763-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207763-004 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207763-005 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207763-006 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A207763-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A207763-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A207763-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A207763-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A207763-005 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A207763-006 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A207763-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207763-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207763-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207763-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207763-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207763-006 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207763-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207763-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207763-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207763-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207763-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207763-006 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A207763-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207763-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207763-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207763-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207763-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207763-006 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207763-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207763-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207763-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207763-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207763-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207763-006 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207763-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207763-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207763-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207763-004 | AB | 1 | b8a1b40f171c… |
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
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LAMOTRIGINE | 50 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| U3H27498KS | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 850091 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| fa679e97-3b3d-4bf2-8de7-da3a89e38b37 | Available on FDA.report |
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. | fa679e97-3b3d-4bf2-8de7-da3a89e38b37 | 2026-07-20 | Boxed warning, Warnings, Adverse reactions | 207763 ANDA207763 70518-4702-0 70518-4702 70518470200 |
| Lamotrigine | LAMOTRIGINE | Zydus Pharmaceuticals USA Inc. | eb436371-d188-4803-a864-07b90c357e57 | 2025-11-12 | Boxed warning, Warnings, Adverse reactions | 207763 ANDA207763 |
| Lamotrigine ER | LAMOTRIGINE ER | Direct_Rx | faccacb7-65f1-cb00-e053-6394a90a9fcb | 2025-01-22 | Boxed warning, Warnings, Adverse reactions | 207763 ANDA207763 |
| Lamotrigine | LAMOTIRIGINE | Zydus Lifesciences Limited | ecb7a528-699f-4e51-9887-dee60456da2f | 2024-11-30 | 207763 ANDA207763 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 70518-4702-0 | 70518470200 | 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-4702-0) | 2026-07-19 | No | No | Current |