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 | Bryant Ranch Prepack | 4bbc140c-6092-416d-865d-49b89c5ecdd0 | 2025-06-16 | Boxed warning, Warnings, Adverse reactions | 198427 U3H27498KS |
| Lamotrigine | LAMOTRIGINE | Bryant Ranch Prepack | cf03f130-067f-401c-8501-0d78a989a319 | 2025-06-16 | Boxed warning, Warnings, Adverse reactions | 198429 U3H27498KS |
| Lamotrigine | LAMOTRIGINE | NuCare Pharmaceuticals,Inc. | 065e97c9-3c5f-16e6-e063-6294a90a13fc | 2025-01-31 | Boxed warning, Warnings, Adverse reactions | 198427 U3H27498KS |
| Lamotrigine ER | LAMOTRIGINE ER | Direct_Rx | faccacb7-65f1-cb00-e053-6394a90a9fcb | 2025-01-22 | Boxed warning, Warnings, Adverse reactions | U3H27498KS |
| LAMOTRIGINE | LAMOTRIGINE | DIRECT RX | a835b697-2beb-1ba8-e053-2995a90a470c | 2025-01-22 | Boxed warning, Warnings, Adverse reactions | ANDA090170 282401 U3H27498KS |
| Lamotrigine | LAMOTRIGINE | Advanced Rx Pharmacy of Tennessee, LLC | f7a86237-ece4-7cc4-e053-6294a90a1308 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | ANDA090170 80425-0289-2 80425-0289-1 80425-0289-3 80425-0289 80425028901 282401 2a9b9724-0258-e829-e063-6394a90a1c07 f7a86237-ece4-7cc4-e053-6294a90a1308 U3H27498KS |
| Lamotrigine | LAMOTRIGINE | Dr.Reddy's Laboratories Limited | 44670496-41ea-36a1-c435-32e359766a74 | 2024-12-19 | Boxed warning, Warnings, Adverse reactions | 282401 198428 198427 198429 U3H27498KS |
| Lamotrigine | LAMOTIRIGINE | Zydus Lifesciences Limited | ecb7a528-699f-4e51-9887-dee60456da2f | 2024-11-30 | U3H27498KS | |
| Lamotrigine | LAMOTRIGINE | Alembic Pharmaceuticals Limited | faee013c-cad2-4abb-904c-e6ff79ba778c | 2024-10-11 | Boxed warning, Warnings, Adverse reactions | U3H27498KS |
| Lamotrigine | LAMOTRIGINE | NCS HealthCare of KY, LLC dba Vangard Labs | e243e803-e95f-47a6-a6da-5fed657f4462 | 2024-08-06 | Boxed warning, Warnings, Adverse reactions | 282401 198428 198427 198429 U3H27498KS |
| LAMOTRIGINE | LAMOTRIGINE | NuCare Pharmaceuticals,Inc. | 1bbbe2a2-a9e8-8c13-e063-6394a90a9627 | 2024-06-25 | Boxed warning, Warnings, Adverse reactions | 198427 U3H27498KS |
| Lamotrigine ER | LAMOTRIGINE ER | Direct_rx | 1b42a7cf-86d8-e506-e063-6394a90a3c9b | 2024-06-19 | Boxed warning, Warnings, Adverse reactions | U3H27498KS |
| Lamotrigine | LAMOTRIGINE | Bryant Ranch Prepack | 36f383af-8b71-4875-85ef-3a7a8b1d8805 | 2024-05-21 | Boxed warning, Warnings, Adverse reactions | U3H27498KS |
| Lamotrigine | LAMOTRIGINE | Proficient Rx LP | ffa46cb2-16e7-45f3-9940-5cb88d0cda9d | 2024-05-01 | Boxed warning, Warnings, Adverse reactions | U3H27498KS |
| Lamotrigine | LAMOTRIGINE | Proficient Rx LP | 6f7e59d2-4311-42a0-93a0-b29b0417d96f | 2024-02-01 | Boxed warning, Warnings, Adverse reactions | ANDA090170 198429 U3H27498KS |
| Lamotrigine | LAMOTRIGINE | A-S Medication Solutions | 5a9575bb-230e-46ae-b58e-41554bad45eb | 2023-11-24 | Boxed warning, Warnings, Adverse reactions | 198428 U3H27498KS |
| lamotrigine | LAMOTRIGINE EXTENDED-RELEASE | Proficient Rx LP | 39efe933-bfed-4a6a-b270-0883871c5186 | 2023-10-01 | Boxed warning, Warnings, Adverse reactions | U3H27498KS |
| LAMOTRIGINE | LAMOTRIGINE | A-S Medication Solutions | 4e6cc1ad-55cd-4c7f-878c-fa6716e95897 | 2023-04-30 | Boxed warning, Warnings, Adverse reactions | 198429 U3H27498KS |
| lamotrigine | LAMOTRIGINE CHEWABLE DISPERSIBLE | Alembic Pharmaceuticals Limited | ae6522d4-d824-44aa-afe0-70cdcbd845af | 2023-01-17 | Boxed warning, Warnings, Adverse reactions | U3H27498KS |
| Lamotrigine | LAMOTRIGINE | Ascend Laboratories, LLC | 70cd448a-2921-4c69-bdf2-5a6ce883bd07 | 2022-12-09 | Boxed warning, Warnings, Adverse reactions | 282401 198428 198427 198429 U3H27498KS |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.