NDC 80425-0305-01 - Mirtazapine
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
- 80425-0305
- Requested NDC
- 80425-0305-01
- Package NDCs from labels
- 80425-0305-1, 80425-0305-2, 80425-0305-3, 80425-0305-01
- 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 |
|---|---|---|---|
| Mirtazapine - 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 |
|---|---|---|---|---|---|---|
| 80425-0305-1 | Mirtazapine | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 2 | |
| 80425-0305-2 | Mirtazapine | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | 2 | |
| 80425-0305-3 | Mirtazapine | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80425-0305 | MIRTAZAPINE TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 2 | Current NDC, 3 package rows | 20250102_f8c383c1-d1b3-ceaa-e053-6294a90a6053.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80425-0305-1 | EA - Each | 80425-0305 | d0b976ed-648c-4682-9747-c9c828babd98 | 1 | 2023-06-06 |
| 80425-0305-2 | EA - Each | 80425-0305 | ae63789d-7e87-4a5b-a0b0-e6fb725b081f | 1 | 2023-06-06 |
| 80425-0305-3 | EA - Each | 80425-0305 | 945dc0c0-5ddc-4cfa-84b4-a8f1b992e112 | 1 | 2023-06-06 |
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 |
|---|---|---|---|---|---|---|
| Mirtazapine | MIRTAZAPINE | REMEDYREPACK INC. | 412abf0e-1f96-4d4d-bb56-a23d4699b14c | 2026-09-04 | Boxed warning, Warnings, Adverse reactions | 311725 A051Q2099Q |
| Mirtazapine | MIRTAZAPINE | NuCare Pharmaceuticals,Inc. | d6fbe837-988a-7c75-e053-2995a90a599a | 2026-08-28 | Boxed warning, Warnings, Adverse reactions | ANDA076921 314111 A051Q2099Q |
| Mirtazapine | MIRTAZAPINE | NuCare Pharmaceuticals,Inc. | e38c96d4-ea33-3f1a-e053-2a95a90a0903 | 2026-08-26 | Boxed warning, Warnings, Adverse reactions | ANDA076921 311725 A051Q2099Q |
| Mirtazapine | MIRTAZAPINE | Coupler LLC | 598e441a-aa1a-6fb3-e063-6394a90a14aa | 2026-08-21 | Boxed warning, Warnings, Adverse reactions | ANDA076921 311725 A051Q2099Q |
| Mirtazapine | MIRTAZAPINE | Redpharm Drug | 58bea4d8-084f-4c30-e063-6394a90a35cb | 2026-08-11 | Boxed warning, Warnings, Adverse reactions | ANDA076921 476809 A051Q2099Q |
| Mirtazapine | MIRTAZAPINE | REMEDYREPACK INC. | 10ea9d83-19c3-4f3b-a1cc-cfc48b42507f | 2026-07-29 | Boxed warning, Warnings, Adverse reactions | ANDA076921 476809 A051Q2099Q |
| Mirtazapine | MIRTAZAPINE | Cardinal Health 107, LLC | 89ae6a33-933f-47aa-a2de-2a71cd3f7d44 | 2026-07-29 | Boxed warning, Warnings, Adverse reactions | 311725 A051Q2099Q |
| mirtazapine | MIRTAZAPINE | XLCare Pharmaceuticals Inc. | b6b31703-e77d-4d1a-b1ac-da972117e356 | 2026-07-24 | Boxed warning, Warnings, Adverse reactions | 476809 311726 311725 314111 A051Q2099Q |
| mirtazapine | MIRTAZAPINE | A-S Medication Solutions | 222dfdde-6979-4b18-a7eb-ff1ad0a437c1 | 2026-07-24 | Boxed warning, Warnings, Adverse reactions | 476809 A051Q2099Q |
| Mirtazapine | MIRTAZAPINE | Bryant Ranch Prepack | 577c3ceb-316b-4c93-9b0c-0a4b1b4773e9 | 2026-07-20 | Boxed warning, Warnings, Adverse reactions | 314111 A051Q2099Q |
| Mirtazapine | MIRTAZAPINE | REMEDYREPACK INC. | 9135e7db-cba4-4150-a69c-fdf2a347a785 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | ANDA076921 311725 A051Q2099Q |
| Mirtazapine | MIRTAZAPINE | Preferred Pharmaceuticals Inc. | c22c4325-4f1a-4d12-8039-d3b1263fa3ad | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | ANDA076921 311725 A051Q2099Q |
| Mirtazapine | MIRTAZAPINE | Preferred Pharmaceuticals Inc. | ac3716fd-6971-4a70-ae7b-9f5117f3d880 | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | ANDA076921 314111 A051Q2099Q |
| Mirtazapine | MIRTAZAPINE | Preferred Pharmaceuticals Inc. | 2a0689ae-5650-42d1-ac9d-56dd2b467727 | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | ANDA076921 311726 A051Q2099Q |
| Mirtazapine | MIRTAZAPINE | Cardinal Health 107, LLC | 7a5545a0-4dbb-48ac-b0d2-477a8dd4b87e | 2026-07-10 | Boxed warning, Warnings, Adverse reactions | 311725 A051Q2099Q |
| Mirtazapine | MIRTAZAPINE | REMEDYREPACK INC. | aae4c58a-5cbd-45ef-b0f9-32bf28204f15 | 2026-07-03 | Boxed warning, Warnings, Adverse reactions | ANDA076921 314111 A051Q2099Q |
| Mirtazapine | MIRTAZAPINE | American Health Packaging | 82a615a0-e74a-49cb-9a57-ffbb3df604d5 | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | ANDA076921 311726 311725 314111 A051Q2099Q |
| Mirtazapine | MIRTAZAPINE | Unit Dose Solutions, Inc. | 5539fe37-546b-40a8-e063-6394a90ace1b | 2026-06-27 | Boxed warning, Warnings, Adverse reactions | ANDA076921 311725 A051Q2099Q |
| Mirtazapine | MIRTAZAPINE | Coupler LLC | 538679a1-d474-8e1c-e063-6394a90a15d7 | 2026-06-05 | Boxed warning, Warnings, Adverse reactions | ANDA076921 476809 A051Q2099Q |
| Mirtazapine | MIRTAZAPINE | Coupler LLC | 53311d08-9dfa-7bb1-e063-6394a90a6656 | 2026-06-01 | Boxed warning, Warnings, Adverse reactions | ANDA076921 311726 A051Q2099Q |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.