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 | American Health Packaging | 3b7a5f44-8da6-4196-bb5d-8d2770af1b3a | 2025-01-07 | Boxed warning, Warnings, Adverse reactions | ANDA076921 476809 A051Q2099Q |
| Mirtazapine | MIRTAZAPINE | Advanced Rx Pharmacy of Tennessee, LLC | f8c383c1-d1b3-ceaa-e053-6294a90a6053 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | ANDA076921 80425-0305-3 80425-0305-2 80425-0305-1 80425-0305 80425030501 311725 2a9ba8f4-6cee-e827-e063-6394a90a0300 f8c383c1-d1b3-ceaa-e053-6294a90a6053 A051Q2099Q |
| Mirtazapine | MIRTAZAPINE | Bryant Ranch Prepack | 3bb242b0-42ed-471a-b3c4-5ded1e292e80 | 2024-11-27 | Boxed warning, Warnings, Adverse reactions | 314111 A051Q2099Q |
| Mirtazapine | MIRTAZAPINE | Bryant Ranch Prepack | c47428e5-4717-4471-9231-ec8b5438205a | 2024-11-13 | Boxed warning, Warnings, Adverse reactions | A051Q2099Q |
| Mirtazapine | MIRTAZAPINE | Aphena Pharma Solutions - Tennessee, LLC | 20eafce1-50cd-0d9c-e063-6394a90ad6fe | 2024-09-13 | Boxed warning, Warnings, Adverse reactions | 311725 A051Q2099Q |
| Mirtazapine | MIRTAZAPINE | Bryant Ranch Prepack | 8c03eb2b-6aed-40a1-a424-67ac1ab6085d | 2024-09-12 | Boxed warning, Warnings, Adverse reactions | 311725 A051Q2099Q |
| Mirtazapine | MIRTAZAPINE | Bryant Ranch Prepack | ecf7826c-c583-4836-9b00-bf9e4b51a144 | 2024-08-20 | Boxed warning, Warnings, Adverse reactions | 311725 A051Q2099Q |
| Mirtazapine | MIRTAZAPINE | Aphena Pharma Solutions - Tennessee, LLC | 1e0006b6-9405-95a7-e063-6294a90aa277 | 2024-07-24 | Boxed warning, Warnings, Adverse reactions | 314111 A051Q2099Q |
| Mirtazapine | MIRTAZAPINE | Bryant Ranch Prepack | ded5b83b-f11a-4a6a-bf77-c5fe6dc4c4f5 | 2024-07-16 | Boxed warning, Warnings, Adverse reactions | 314111 A051Q2099Q |
| Mirtazapine | MIRTAZAPINE | Aphena Pharma Solutions - Tennessee, LLC | ac976282-fb68-4db0-912a-28f075b0716c | 2024-06-28 | Boxed warning, Warnings, Adverse reactions | 314111 A051Q2099Q |
| Mirtazapine | MIRTAZAPINE | NuCare Pharmaceuticals,Inc. | 8e839bb2-2f67-f224-e053-2a95a90ae5d8 | 2024-06-18 | Boxed warning, Warnings, Adverse reactions | ANDA076921 314111 A051Q2099Q |
| Mirtazapine | MIRTAZAPINE | Golden State Medical Supply, Inc. | a6a5949f-5ebf-f37d-e053-2995a90adae5 | 2024-06-14 | Boxed warning, Warnings, Adverse reactions | 311726 311725 314111 A051Q2099Q |
| Mirtazapine | MIRTAZAPINE | Bryant Ranch Prepack | 9f0f52e8-3318-4da2-b0d9-ea3d33bfe41e | 2023-10-26 | Boxed warning, Warnings, Adverse reactions | 311725 A051Q2099Q |
| Mirtazapine | MIRTAZAPINE | NCS HealthCare of KY, LLC dba Vangard Labs | 70439462-b632-4d21-8067-560162db3137 | 2023-09-18 | Boxed warning, Warnings, Adverse reactions | ANDA076921 476809 A051Q2099Q |
| Mirtazapine | MIRTAZAPINE | Bryant Ranch Prepack | 1ba111d1-cf92-4cd9-afcb-3bebd1bacd46 | 2023-08-28 | Boxed warning, Warnings, Adverse reactions | 311725 A051Q2099Q |
| Mirtazapine | MIRTAZAPINE | SQUARE PHARMACEUTICALS LIMITED | 83093852-d212-408e-98fd-33f4603a9d65 | 2023-07-02 | A051Q2099Q | |
| Mirtazapine | MIRTAZAPINE | Aphena Pharma Solutions - Tennessee, LLC | faba9bfd-6725-4917-ab48-24e58b397eb4 | 2023-06-29 | Boxed warning, Warnings, Adverse reactions | 311725 A051Q2099Q |
| Mirtazapine | MIRTAZAPINE | Aphena Pharma Solutions - Tennessee, LLC | 50ccc34a-4b89-4b07-b153-6c71c6924db1 | 2023-06-06 | Boxed warning, Warnings, Adverse reactions | 314111 A051Q2099Q |
| Mirtazapine | MIRTAZAPINE | Prasco Laboratories | 8b2a08f7-4803-42fa-a2b5-5ea51f8ef7e4 | 2023-02-01 | Boxed warning, Warnings, Adverse reactions | 476809 311726 311725 314111 A051Q2099Q |
| Mirtazapine | MIRTAZAPINE | Mylan Pharmaceuticals Inc. | 711aa80b-8fc6-49e6-9494-3db31d9b53a4 | 2022-10-04 | Boxed warning, Warnings, Adverse reactions | 311726 311725 314111 A051Q2099Q |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.