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 | Northstar Rx LLC. | aabc64fe-1f17-4140-81f2-7d4506db6c8b | 2025-12-31 | Boxed warning, Warnings, Adverse reactions | 282401 198428 198427 198429 U3H27498KS |
| lamotrigine | LAMOTRIGINE EXTENDED-RELEASE | Yiling Pharmaceutical, Inc. | f7de11a5-5357-4753-b1ac-b15123b50028 | 2025-12-29 | Boxed warning, Warnings, Adverse reactions | U3H27498KS |
| Lamotrigine | LAMOTRIGINE | A-S Medication Solutions | 84277e2c-370c-4510-92bc-ef33a4a0f508 | 2025-12-05 | Boxed warning, Warnings, Adverse reactions | ANDA090170 198429 U3H27498KS |
| Lamotrigine | LAMOTRIGINE | Amneal Pharmaceuticals of New York LLC | 9e5c2d76-47a6-4a57-b23c-2398b307380c | 2025-12-04 | Boxed warning, Warnings, Adverse reactions | U3H27498KS |
| Lamotrigine | LAMOTRIGINE | Ajanta Pharma USA Inc. | 9dfb5f87-0150-4c26-a89f-34f1ab389500 | 2025-11-26 | Boxed warning, Warnings, Adverse reactions | U3H27498KS |
| Lamotrigine | LAMOTRIGINE | Dr.Reddy's Laboratories Limited | a69542ea-5b6f-15c1-9e7a-90ac839971d3 | 2025-11-21 | Boxed warning, Warnings, Adverse reactions | U3H27498KS |
| Lamotrigine | LAMOTRIGINE | NorthStar Rx LLC | 9ab07d6b-ae4a-a310-5572-b266676cd29e | 2025-11-20 | Boxed warning, Warnings, Adverse reactions | U3H27498KS |
| Lamotrigine | LAMOTRIGINE | Advagen Pharma Limited | 4ca9d713-ab63-48bf-9386-29301a842e60 | 2025-11-19 | Boxed warning, Warnings, Adverse reactions | 282401 198428 198427 198429 U3H27498KS |
| Lamotrigine | LAMOTRIGINE | Zydus Pharmaceuticals USA Inc. | e849033b-a3bc-408e-88de-7cd1d2660949 | 2025-11-14 | Boxed warning, Warnings, Adverse reactions | 282401 198428 198427 198429 U3H27498KS |
| Lamotrigine | LAMOTRIGINE | Zydus Pharmaceuticals USA Inc. | eb436371-d188-4803-a864-07b90c357e57 | 2025-11-12 | Boxed warning, Warnings, Adverse reactions | U3H27498KS |
| LAMICTAL | LAMOTRIGINE | GlaxoSmithKline LLC | d7e3572d-56fe-4727-2bb4-013ccca22678 | 2025-10-10 | Boxed warning, Warnings, Adverse reactions | 282401 198428 198427 198429 U3H27498KS |
| LAMICTAL XR | LAMOTRIGINE | GlaxoSmithKline LLC | 3e2c9a35-6a39-41d7-ad84-3c0bb8894b09 | 2025-10-10 | Boxed warning, Warnings, Adverse reactions | U3H27498KS |
| Lamotrigine | LAMOTRIGINE | Zydus Lifesciences Limited | 0f2f7421-56d4-45d0-9d2d-dc1edaede039 | 2025-10-04 | 282401 198428 198427 198429 U3H27498KS | |
| Lamotrigine | LAMOTRIGINE | Bryant Ranch Prepack | 8e1e4fa8-881c-4618-88f6-018ab15db44d | 2025-09-18 | Boxed warning, Warnings, Adverse reactions | ANDA090170 198428 U3H27498KS |
| Lamotrigine | LAMOTRIGINE | Bryant Ranch Prepack | 812bc0d8-bb31-4fb1-9f4a-f8c17cbc769c | 2025-09-17 | Boxed warning, Warnings, Adverse reactions | ANDA090170 198429 U3H27498KS |
| Lamotrigine | LAMOTRIGINE | Bryant Ranch Prepack | 53774022-ea0c-42a9-a720-dc755c77b851 | 2025-09-17 | Boxed warning, Warnings, Adverse reactions | ANDA090170 198427 U3H27498KS |
| Lamotrigine | LAMOTRIGINE | Coupler LLC | 3dfdcc2d-b7c5-7abf-e063-6394a90a24a6 | 2025-09-04 | Boxed warning, Warnings, Adverse reactions | 282401 U3H27498KS |
| Lamotrigine | LAMOTRIGINE | Bryant Ranch Prepack | d33c4293-347c-49a1-9d98-f291c3dab6da | 2025-09-04 | Boxed warning, Warnings, Adverse reactions | 198428 U3H27498KS |
| Lamotrigine | LAMOTRIGINE | Jubilant Cadista Pharmacuticals Inc. | 0b0f0209-edbd-46f3-9bed-762cbea0d737 | 2025-07-15 | Boxed warning, Warnings, Adverse reactions | 282401 198428 198427 198429 U3H27498KS |
| Lamotrigine | LAMOTRIGINE | Bryant Ranch Prepack | 2cf33586-e48a-4b4e-b14b-33de2be63c1d | 2025-06-16 | Boxed warning, Warnings, Adverse reactions | 282401 U3H27498KS |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.