Lamotrigine
- Product NDC
- 70518-1153
- 11-digit product format
- 705181153
- Labeler code
- 70518
- Product ID
- 70518-1153_50708c02-4ac2-2ebe-e063-6294a90ab303
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA203370
- Marketing category
- ANDA
- Marketing start
- 2018-05-01
- 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
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 70518-1153 | 70518-1153-0 | D | Discontinued by firm | 2026-08-11 |
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 | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 70518-1153-0 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 70518-1153-0 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 70518-1153-0 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 70518-1153-0 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 70518-1153-0 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 70518-1153-0 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 70518-1153-0 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 70518-1153-0 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 70518-1153-0 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 70518-1153-0 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 70518-1153-0 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 70518-1153-0 | 557ba5c1ecfa… | 9c80585c8c6e… |
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 | 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 |
|---|---|
| de7f61ca-e3c0-4a09-b664-0df2de6a0c30 | 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 |
|---|---|---|---|---|---|---|
| 70518-1153-0 | Lamotrigine | 30 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 30 | 5 | |
| 70518-1153-1 | Lamotrigine | 50 in 1 BOX | TABLET, EXTENDED RELEASE | 50 | 5 | |
| 70518-1153-2 | Lamotrigine | 1 in 1 POUCH | TABLET, EXTENDED RELEASE | 1 | 5 |
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 70518-1153 |
| Lamotrigine | LAMOTRIGINE | Torrent Pharmaceuticals Limited | 52df02a7-83da-4b20-9951-69790237dc24 | 2026-03-04 | Boxed warning, Warnings, Adverse reactions | 203370 ANDA203370 |
| 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 |
|---|---|---|---|---|
| 850091 | lamoTRIgine 50 MG 24HR Extended Release Oral Tablet | PSN | de7f61ca-e3c0-4a09-b664-0df2de6a0c30 | 5 |
| 850091 | 24 HR lamotrigine 50 MG Extended Release Oral Tablet | SCD | de7f61ca-e3c0-4a09-b664-0df2de6a0c30 | 5 |
| 850091 | lamotrigine 50 MG 24 HR Extended Release Oral Tablet | SY | de7f61ca-e3c0-4a09-b664-0df2de6a0c30 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 70518-1153-0 | 70518115300 | 30 in 1 BLISTER PACK | Historical | ||||
| 70518-1153-1 | 70518115301 | 50 POUCH in 1 BOX (70518-1153-1) / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-1153-2) | 50 pouch | 2026-04-24 | No | No | Current |
| 70518-1153-2 | 70518115302 | 1 in 1 POUCH | Historical |