Mirtazapine
- Product NDC
- 55154-8145
- 11-digit product format
- 551548145
- Labeler code
- 55154
- Product ID
- 55154-8145_87b2d33f-e9d1-45b1-a1aa-2b7e94899048
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mirtazapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Cardinal Health 107, LLC
- Application
- ANDA077666
- Marketing category
- ANDA
- Marketing start
- 2007-08-22
- Marketing end
- 0000-00-00
- Substance
- MIRTAZAPINE
- Active strength
- 30 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 product | product | 55154-8145 | D | Discontinued by firm | 2026-08-10 | ||
| excluded package | package | 55154-8145 | 55154-8145-0 | D | Discontinued by firm | 2026-08-10 |
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 | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 55154-8145-0 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 55154-8145-0 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 55154-8145-0 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 55154-8145-0 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 55154-8145-0 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 55154-8145-0 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 55154-8145-0 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 55154-8145-0 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 55154-8145-0 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 55154-8145-0 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 55154-8145-0 | 367a005e9d99… | 383a685ebd0f… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077666-001 | MIRTAZAPINE | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2007-08-22 | |
| A077666-002 | MIRTAZAPINE | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2007-08-22 | |
| A077666-003 | MIRTAZAPINE | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2007-08-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077666-001 | AB |
| A077666-002 | AB |
| A077666-003 | 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 | A077666-001 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2007-08-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077666-002 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2007-08-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077666-003 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2007-08-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077666-001 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2007-08-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077666-002 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2007-08-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077666-003 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2007-08-22 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077666-001 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2007-08-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077666-002 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2007-08-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077666-003 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2007-08-22 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077666-001 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2007-08-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077666-002 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2007-08-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077666-003 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2007-08-22 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077666-001 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2007-08-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077666-002 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2007-08-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077666-003 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2007-08-22 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077666-001 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2007-08-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077666-002 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2007-08-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077666-003 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2007-08-22 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077666-001 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2007-08-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077666-002 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2007-08-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077666-003 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2007-08-22 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077666-001 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2007-08-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077666-002 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2007-08-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077666-003 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2007-08-22 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077666-001 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2007-08-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077666-002 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2007-08-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077666-003 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2007-08-22 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077666-001 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2007-08-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077666-002 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2007-08-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077666-003 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2007-08-22 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077666-001 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2007-08-22 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077666-002 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2007-08-22 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077666-003 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2007-08-22 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077666-001 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2007-08-22 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077666-002 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2007-08-22 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077666-003 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2007-08-22 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077666-001 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2007-08-22 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077666-002 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2007-08-22 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077666-003 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2007-08-22 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A077666-001 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2007-08-22 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A077666-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077666-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077666-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077666-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077666-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077666-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077666-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077666-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077666-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077666-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077666-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077666-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077666-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077666-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077666-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077666-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077666-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077666-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077666-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077666-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077666-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077666-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077666-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077666-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077666-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077666-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077666-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077666-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077666-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077666-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077666-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077666-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077666-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077666-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077666-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077666-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077666-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077666-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077666-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A077666-001 | AB | 1 | 8072bd15b7f6… |
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 | A-S Medication Solutions | 44779383-3ddb-41df-8766-da5d7bef385e | 2026-01-14 | Boxed warning, Warnings, Adverse reactions | 077666 ANDA077666 |
| Mirtazapine | MIRTAZAPINE | Direct_Rx | dea8c09a-b759-1da7-e053-2a95a90a3346 | 2026-01-08 | Warnings, Adverse reactions | 077666 ANDA077666 |
| Mirtazapine | MIRTAZAPINE | Cardinal Health 107, LLC | df06ea51-a962-49d0-a449-137e2220ce7e | 2025-10-22 | Boxed warning, Warnings, Adverse reactions | 077666 ANDA077666 |
| Mirtazapine | MIRTAZAPINE | Apotex Corp. | 9675333e-3064-c8cb-a4b4-6c74d9a82f17 | 2025-09-19 | Boxed warning, Warnings, Adverse reactions | 077666 ANDA077666 |
| Mirtazapine | MIRTAZAPINE | Coupler LLC | 3eed8213-a240-fc4b-e063-6294a90a3b05 | 2025-09-16 | Boxed warning, Warnings, Adverse reactions | 077666 ANDA077666 |
| Mirtazapine | MIRTAZAPINE | Major Pharmaceuticals | a80463be-f2d2-4074-9bd8-5e52b0832b3a | 2025-07-15 | Boxed warning, Warnings, Adverse reactions | 077666 ANDA077666 |
| Mirtazapine | MIRTAZAPINE | AvKARE | 35922615-7619-3852-e063-6394a90a2e55 | 2025-05-20 | Boxed warning, Warnings, Adverse reactions | 077666 ANDA077666 |
| Mirtazapine | MIRTAZAPINE | McKesson Corporation dba SKY Packaging | 40c95daa-bbd5-48d9-97e4-c87f2c1f0fa5 | 2025-01-14 | Boxed warning, Warnings, Adverse reactions | 077666 ANDA077666 |
| Mirtazapine | MIRTAZAPINE | Aphena Pharma Solutions - Tennessee, LLC | ac976282-fb68-4db0-912a-28f075b0716c | 2024-06-28 | Boxed warning, Warnings, Adverse reactions | 077666 ANDA077666 |
| Mirtazapine | MIRTAZAPINE | Aphena Pharma Solutions - Tennessee, LLC | faba9bfd-6725-4917-ab48-24e58b397eb4 | 2023-06-29 | Boxed warning, Warnings, Adverse reactions | 077666 ANDA077666 |
| Mirtazapine | MIRTAZAPINE | Proficient Rx LP | 3b516a33-b164-4e4f-bc18-e9d1e591323a | 2022-10-01 | Boxed warning, Warnings, Adverse reactions | 077666 ANDA077666 |
| Mirtazapine | MIRTAZAPINE | Proficient Rx LP | a2f01ffd-fd48-499b-9126-8eb9048a5722 | 2022-05-02 | Boxed warning, Warnings, Adverse reactions | 077666 ANDA077666 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55154-8145-0 | 55154814500 | 10 BLISTER PACK in 1 BAG (55154-8145-0) > 1 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2019-11-15 | 0000-00-00 | No | No | Current |