Mirtazapine
- Product NDC
- 55154-7141
- Requested package NDC
- 55154-7141-0
- 11-digit product format
- 551547141
- Labeler code
- 55154
- Product ID
- 55154-7141_72b404cb-4708-4a42-ace4-e2fb3aa3a7de
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mirtazapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Cardinal Health
- Application
- ANDA076921
- Marketing category
- ANDA
- Marketing start
- 2005-10-25
- Marketing end
- 0000-00-00
- Substance
- MIRTAZAPINE
- Active strength
- 30 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 55154-7141 | 55154-7141-0 | D | Discontinued by firm | 2026-08-07 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076921-001 | MIRTAZAPINE | MIRTAZAPINE | 7.5MG | TABLET / ORAL | AB | 2004-10-22 | |
| A076921-002 | MIRTAZAPINE | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2004-10-22 | |
| A076921-003 | MIRTAZAPINE | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2004-10-22 | |
| A076921-004 | MIRTAZAPINE | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2004-10-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076921-001 | AB |
| A076921-002 | AB |
| A076921-003 | AB |
| A076921-004 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A076921-001 | MIRTAZAPINE | 7.5MG | TABLET / ORAL | AB | 2004-10-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076921-002 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2004-10-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076921-003 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2004-10-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076921-004 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2004-10-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076921-001 | MIRTAZAPINE | 7.5MG | TABLET / ORAL | AB | 2004-10-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076921-002 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2004-10-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076921-003 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2004-10-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076921-004 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2004-10-22 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076921-001 | MIRTAZAPINE | 7.5MG | TABLET / ORAL | AB | 2004-10-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076921-002 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2004-10-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076921-003 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2004-10-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076921-004 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2004-10-22 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076921-001 | MIRTAZAPINE | 7.5MG | TABLET / ORAL | AB | 2004-10-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076921-002 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2004-10-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076921-003 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2004-10-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076921-004 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2004-10-22 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076921-001 | MIRTAZAPINE | 7.5MG | TABLET / ORAL | AB | 2004-10-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076921-002 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2004-10-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076921-003 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2004-10-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076921-004 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2004-10-22 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076921-001 | MIRTAZAPINE | 7.5MG | TABLET / ORAL | AB | 2004-10-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076921-002 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2004-10-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076921-003 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2004-10-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076921-004 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2004-10-22 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076921-001 | MIRTAZAPINE | 7.5MG | TABLET / ORAL | AB | 2004-10-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076921-002 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2004-10-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076921-003 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2004-10-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076921-004 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2004-10-22 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076921-001 | MIRTAZAPINE | 7.5MG | TABLET / ORAL | AB | 2004-10-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076921-002 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2004-10-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076921-003 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2004-10-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076921-004 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2004-10-22 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076921-001 | MIRTAZAPINE | 7.5MG | TABLET / ORAL | AB | 2004-10-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076921-002 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2004-10-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076921-003 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2004-10-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076921-004 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2004-10-22 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076921-001 | MIRTAZAPINE | 7.5MG | TABLET / ORAL | AB | 2004-10-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076921-002 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2004-10-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076921-003 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2004-10-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076921-004 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2004-10-22 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A076921-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076921-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076921-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076921-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076921-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076921-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076921-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076921-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076921-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076921-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076921-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076921-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076921-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076921-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076921-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076921-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076921-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076921-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076921-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076921-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076921-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076921-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076921-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076921-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076921-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076921-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076921-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076921-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076921-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076921-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076921-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076921-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076921-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076921-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076921-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076921-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A076921-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076921-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076921-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076921-004 | AB | 1 | d06236e962d9… |
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. | 10ea9d83-19c3-4f3b-a1cc-cfc48b42507f | 2026-07-29 | Boxed warning, Warnings, Adverse reactions | 076921 ANDA076921 |
| Mirtazapine | MIRTAZAPINE | REMEDYREPACK INC. | 9135e7db-cba4-4150-a69c-fdf2a347a785 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | 076921 ANDA076921 |
| Mirtazapine | MIRTAZAPINE | Preferred Pharmaceuticals Inc. | c22c4325-4f1a-4d12-8039-d3b1263fa3ad | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | 076921 ANDA076921 |
| Mirtazapine | MIRTAZAPINE | Preferred Pharmaceuticals Inc. | ac3716fd-6971-4a70-ae7b-9f5117f3d880 | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | 076921 ANDA076921 |
| Mirtazapine | MIRTAZAPINE | Preferred Pharmaceuticals Inc. | 2a0689ae-5650-42d1-ac9d-56dd2b467727 | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | 076921 ANDA076921 |
| Mirtazapine | MIRTAZAPINE | REMEDYREPACK INC. | aae4c58a-5cbd-45ef-b0f9-32bf28204f15 | 2026-07-03 | Boxed warning, Warnings, Adverse reactions | 076921 ANDA076921 |
| Mirtazapine | MIRTAZAPINE | American Health Packaging | 82a615a0-e74a-49cb-9a57-ffbb3df604d5 | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | 076921 ANDA076921 |
| Mirtazapine | MIRTAZAPINE | Unit Dose Solutions, Inc. | 5539fe37-546b-40a8-e063-6394a90ace1b | 2026-06-27 | Boxed warning, Warnings, Adverse reactions | 076921 ANDA076921 |
| Mirtazapine | MIRTAZAPINE | Coupler LLC | 538679a1-d474-8e1c-e063-6394a90a15d7 | 2026-06-05 | Boxed warning, Warnings, Adverse reactions | 076921 ANDA076921 |
| Mirtazapine | MIRTAZAPINE | Coupler LLC | 53311d08-9dfa-7bb1-e063-6394a90a6656 | 2026-06-01 | Boxed warning, Warnings, Adverse reactions | 076921 ANDA076921 |
| Mirtazapine | MIRTAZAPINE | Coupler LLC | 51269807-2b5a-e7aa-e063-6394a90ab657 | 2026-05-06 | Boxed warning, Warnings, Adverse reactions | 076921 ANDA076921 |
| Mirtazapine | MIRTAZAPINE | Coupler LLC | 50718832-88fb-dec1-e063-6294a90ae468 | 2026-04-27 | Boxed warning, Warnings, Adverse reactions | 076921 ANDA076921 |
| Mirtazapine | MIRTAZAPINE | A-S Medication Solutions | 552e2261-53db-4a27-b277-f7b62c3ea2ed | 2026-02-12 | Boxed warning, Warnings, Adverse reactions | 076921 ANDA076921 |
| Mirtazapine | MIRTAZAPINE | REMEDYREPACK INC. | 1b13d7ec-ecdc-482c-8fe2-b999bab3bbeb | 2026-02-09 | Boxed warning, Warnings, Adverse reactions | 076921 ANDA076921 |
| Mirtazapine | MIRTAZAPINE | REMEDYREPACK INC. | f54718d1-3ef7-4472-9e97-90e5fd30db4d | 2026-02-06 | Boxed warning, Warnings, Adverse reactions | 076921 ANDA076921 |
| Mirtazapine | MIRTAZAPINE | Bryant Ranch Prepack | 6b6e946c-54b5-40e3-918f-9cc29f04cd9a | 2026-02-02 | Boxed warning, Warnings, Adverse reactions | 076921 ANDA076921 |
| Mirtazapine | MIRTAZAPINE | REMEDYREPACK INC. | 81d9e47e-ae81-4755-a5ee-546a038fadb4 | 2026-01-28 | Boxed warning, Warnings, Adverse reactions | 076921 ANDA076921 |
| Mirtazapine | MIRTAZAPINE | Bryant Ranch Prepack | 7727fe84-f6cc-4b31-bc00-1ecf741ad361 | 2026-01-23 | Boxed warning, Warnings, Adverse reactions | 076921 ANDA076921 |
| Mirtazapine | MIRTAZAPINE | A-S Medication Solutions | 67e753ad-9919-416b-9e8f-aab0fa808066 | 2026-01-14 | Boxed warning, Warnings, Adverse reactions | 076921 ANDA076921 |
| Mirtazapine | MIRTAZAPINE | REMEDYREPACK INC. | d1b59d87-8442-4c15-8bb9-e39b198d8677 | 2026-01-08 | Boxed warning, Warnings, Adverse reactions | 076921 ANDA076921 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55154-7141-0 | 55154714100 | 10 BLISTER PACK in 1 BAG (55154-7141-0) > 1 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2005-10-25 | 0000-00-00 | No | No | Current |