NDC 80425-0289-01 - Lamotrigine
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 80425-0289
- Requested NDC
- 80425-0289-01
- Package NDCs from labels
- 80425-0289-1, 80425-0289-2, 80425-0289-3, 80425-0289-01
- Manufacturer
- Advanced Rx Pharmacy of Tennessee, LLC
- Effective date
- 2024-12-31
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Lamotrigine - Advanced Rx Pharmacy of Tennessee, LLC | Advanced Rx Pharmacy of Tennessee, LLC | 2024-12-31 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80425-0289-1 | Lamotrigine | 30 in 1 BOTTLE | TABLET | 30 | 2 | |
| 80425-0289-2 | Lamotrigine | 60 in 1 BOTTLE | TABLET | 60 | 2 | |
| 80425-0289-3 | Lamotrigine | 90 in 1 BOTTLE | TABLET | 90 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80425-0289 | LAMOTRIGINE TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 2 | Current NDC, 3 package rows | 20250102_f7a86237-ece4-7cc4-e053-6294a90a1308.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80425-0289-1 | EA - Each | 80425-0289 | 902fd383-e045-4a04-90d7-c3bbdb9daed7 | 1 | 2023-04-07 |
| 80425-0289-2 | EA - Each | 80425-0289 | ad005172-4479-47ce-9e8b-01da723d13c1 | 1 | 2023-04-07 |
| 80425-0289-3 | EA - Each | 80425-0289 | cf9f90dc-57c1-4142-8119-8d5139a8e744 | 1 | 2023-04-07 |
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. | 3ed4590d-71e3-4208-b6c0-98330acc7b85 | 2026-07-06 | Boxed warning, Warnings, Adverse reactions | ANDA090170 198429 U3H27498KS |
| Lamotrigine | LAMOTRIGINE | REMEDYREPACK INC. | de7f61ca-e3c0-4a09-b664-0df2de6a0c30 | 2026-07-03 | Boxed warning, Warnings, Adverse reactions | U3H27498KS |
| Lamotrigine | LAMOTRIGINE | Coupler LLC | 545fcc0e-1e2b-bdcb-e063-6294a90a4ac7 | 2026-06-16 | Boxed warning, Warnings, Adverse reactions | ANDA090170 198428 U3H27498KS |
| Lamotrigine | LAMOTRIGINE | Bryant Ranch Prepack | b1601109-5c17-4482-9257-1e0be7546e8f | 2026-06-11 | Boxed warning, Warnings, Adverse reactions | ANDA090170 282401 U3H27498KS |
| SUBVENITE | LAMOTRIGINE | OWP Pharmaceuticals, Inc. | 022b0913-f683-4af8-a862-f81b315909b2 | 2026-06-04 | Boxed warning, Warnings, Adverse reactions | U3H27498KS |
| Lamotrigine | LAMOTRIGINE | Sun Pharmaceutical Industries, Inc. | b829f9b2-f0ac-408a-a6f4-18b72150227d | 2026-06-03 | Boxed warning, Warnings, Adverse reactions | 282401 198428 198427 198429 U3H27498KS |
| Lamotrigine | LAMOTRIGINE | Bryant Ranch Prepack | 68a4dac2-5015-40c5-88ca-204098c3b288 | 2026-05-28 | Boxed warning, Warnings, Adverse reactions | 198428 U3H27498KS |
| Lamotrigine | LAMOTRIGINE | Coupler LLC | 52b8be5c-ef88-dfa7-e063-6394a90a0500 | 2026-05-26 | Boxed warning, Warnings, Adverse reactions | ANDA090170 198427 U3H27498KS |
| Lamotrigine | LAMOTRIGINE | Aurobindo Pharma Limited | a9a4309e-fe43-4a26-a30f-c6577d650336 | 2026-05-25 | Boxed warning, Warnings, Adverse reactions | 282401 198428 198427 198429 U3H27498KS |
| Lamotrigine | LAMOTRIGINE | Alembic Pharmaceuticals Limited | ccb33cd0-e5f7-4a50-8b55-ad7c432cdb77 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | 282401 198428 198427 198429 U3H27498KS |
| Lamotrigine | LAMOTRIGINE | Unichem Pharmaceuticals (USA), Inc. | 4b72ea7a-a0b0-4980-84ad-84f64e2e6368 | 2026-05-19 | Boxed warning, Warnings, Adverse reactions | ANDA090170 29300-111 282401 198428 198427 198429 503a737a-92a2-4a67-bfbb-e08788c101df 4b72ea7a-a0b0-4980-84ad-84f64e2e6368 U3H27498KS |
| Lamotrigine | LAMOTRIGINE | Preferred Pharmaceuticals, Inc. | 16323699-9bf8-43c7-b3aa-589156377872 | 2026-05-18 | Boxed warning, Warnings, Adverse reactions | ANDA090170 282401 U3H27498KS |
| Lamotrigine | LAMOTRIGINE | Preferred Pharmaceuticals Inc. | 09a0d30d-9b8f-4c76-8cdb-8492386b2254 | 2026-05-18 | Boxed warning, Warnings, Adverse reactions | ANDA090170 198427 U3H27498KS |
| Lamotrigine | LAMOTRIGINE | AvKARE | fcdb94a8-33be-6375-98ef-6933999d157f | 2026-05-13 | Boxed warning, Warnings, Adverse reactions | 282401 198428 198427 198429 U3H27498KS |
| Lamotrigine | LAMOTRIGINE | Major Pharmaceuticals | 12e0be85-0961-4fe0-b973-83251ecf0f65 | 2026-05-04 | Boxed warning, Warnings, Adverse reactions | 282401 198427 U3H27498KS |
| Lamotrigine | LAMOTRIGINE | Actavis Pharma, Inc. | 87beaf22-593d-4170-bb58-332c615ef90d | 2026-04-28 | Boxed warning, Warnings, Adverse reactions | U3H27498KS |
| lamotrigine | LAMOTRIGINE EXTENDED-RELEASE | REMEDYREPACK INC. | 65748114-c59c-4ebb-977e-d4aab5764dd3 | 2026-04-27 | Boxed warning, Warnings, Adverse reactions | U3H27498KS |
| Lamotrigine | LAMOTRIGINE | Par Health USA, LLC | 003663e5-c0c7-4fc1-a64d-313f2a5b10d2 | 2026-04-22 | Boxed warning, Warnings, Adverse reactions | U3H27498KS |
| Lamotrigine | LAMOTRIGINE | Nordic Pharma, Inc. | 67cf961e-02b9-4a99-944f-43a55df6a544 | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | U3H27498KS |
| LAMOTRIGINE Kit | LAMOTRIGINE | OWP Pharmaceuticals, Inc. | 474fb321-575c-4b97-9dbe-080061652ee4 | 2026-03-27 | Boxed warning, Warnings, Adverse reactions | 282401 198427 U3H27498KS |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.