ESZOPICLONE
- Product NDC
- 70518-3395
- 11-digit product format
- 705183395
- Labeler code
- 70518
- Product ID
- 70518-3395_e5fa3940-05d4-c20a-e053-2995a90a3477
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ESZOPICLONE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA208451
- Marketing category
- ANDA
- Marketing start
- 2022-03-24
- Marketing end
- 0000-00-00
- Substance
- ESZOPICLONE
- Active strength
- 3 mg/1
- DEA schedule
- CIV
- 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 | 70518-3395 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 70518-3395 | 70518-3395-0 | D | Discontinued by firm | 2026-08-03 |
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 | 70518-3395-0 | 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 | 70518-3395-0 | 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 | 70518-3395-0 | 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 | 70518-3395-0 | 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 | 70518-3395-0 | 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 | 70518-3395-0 | 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 | 70518-3395-0 | 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 | 70518-3395-0 | 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 | 70518-3395-0 | 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 | 70518-3395-0 | ad56d346431e… | cc804d4bbf1e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A208451-001 | ESZOPICLONE | ESZOPICLONE | 1MG | TABLET / ORAL | AB | 2016-09-15 | |
| A208451-002 | ESZOPICLONE | ESZOPICLONE | 2MG | TABLET / ORAL | AB | 2016-09-15 | |
| A208451-003 | ESZOPICLONE | ESZOPICLONE | 3MG | TABLET / ORAL | AB | 2016-09-15 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A208451-001 | AB |
| A208451-002 | AB |
| A208451-003 | 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 | A208451-001 | ESZOPICLONE | 1MG | TABLET / ORAL | AB | 2016-09-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208451-002 | ESZOPICLONE | 2MG | TABLET / ORAL | AB | 2016-09-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208451-003 | ESZOPICLONE | 3MG | TABLET / ORAL | AB | 2016-09-15 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208451-001 | ESZOPICLONE | 1MG | TABLET / ORAL | AB | 2016-09-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208451-002 | ESZOPICLONE | 2MG | TABLET / ORAL | AB | 2016-09-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208451-003 | ESZOPICLONE | 3MG | TABLET / ORAL | AB | 2016-09-15 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208451-001 | ESZOPICLONE | 1MG | TABLET / ORAL | AB | 2016-09-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208451-002 | ESZOPICLONE | 2MG | TABLET / ORAL | AB | 2016-09-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208451-003 | ESZOPICLONE | 3MG | TABLET / ORAL | AB | 2016-09-15 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208451-001 | ESZOPICLONE | 1MG | TABLET / ORAL | AB | 2016-09-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208451-002 | ESZOPICLONE | 2MG | TABLET / ORAL | AB | 2016-09-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208451-003 | ESZOPICLONE | 3MG | TABLET / ORAL | AB | 2016-09-15 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208451-001 | ESZOPICLONE | 1MG | TABLET / ORAL | AB | 2016-09-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208451-002 | ESZOPICLONE | 2MG | TABLET / ORAL | AB | 2016-09-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208451-003 | ESZOPICLONE | 3MG | TABLET / ORAL | AB | 2016-09-15 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208451-001 | ESZOPICLONE | 1MG | TABLET / ORAL | AB | 2016-09-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208451-002 | ESZOPICLONE | 2MG | TABLET / ORAL | AB | 2016-09-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208451-003 | ESZOPICLONE | 3MG | TABLET / ORAL | AB | 2016-09-15 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208451-001 | ESZOPICLONE | 1MG | TABLET / ORAL | AB | 2016-09-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208451-002 | ESZOPICLONE | 2MG | TABLET / ORAL | AB | 2016-09-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208451-003 | ESZOPICLONE | 3MG | TABLET / ORAL | AB | 2016-09-15 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208451-001 | ESZOPICLONE | 1MG | TABLET / ORAL | AB | 2016-09-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208451-002 | ESZOPICLONE | 2MG | TABLET / ORAL | AB | 2016-09-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208451-003 | ESZOPICLONE | 3MG | TABLET / ORAL | AB | 2016-09-15 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208451-001 | ESZOPICLONE | 1MG | TABLET / ORAL | AB | 2016-09-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208451-002 | ESZOPICLONE | 2MG | TABLET / ORAL | AB | 2016-09-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208451-003 | ESZOPICLONE | 3MG | TABLET / ORAL | AB | 2016-09-15 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A208451-001 | ESZOPICLONE | 1MG | TABLET / ORAL | AB | 2016-09-15 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A208451-002 | ESZOPICLONE | 2MG | TABLET / ORAL | AB | 2016-09-15 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A208451-003 | ESZOPICLONE | 3MG | TABLET / ORAL | AB | 2016-09-15 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208451-001 | ESZOPICLONE | 1MG | TABLET / ORAL | AB | 2016-09-15 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208451-002 | ESZOPICLONE | 2MG | TABLET / ORAL | AB | 2016-09-15 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208451-003 | ESZOPICLONE | 3MG | TABLET / ORAL | AB | 2016-09-15 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A208451-001 | ESZOPICLONE | 1MG | TABLET / ORAL | AB | 2016-09-15 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A208451-002 | ESZOPICLONE | 2MG | TABLET / ORAL | AB | 2016-09-15 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A208451-003 | ESZOPICLONE | 3MG | TABLET / ORAL | AB | 2016-09-15 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A208451-001 | ESZOPICLONE | 1MG | TABLET / ORAL | AB | 2016-09-15 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A208451-002 | ESZOPICLONE | 2MG | TABLET / ORAL | AB | 2016-09-15 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A208451-003 | ESZOPICLONE | 3MG | TABLET / ORAL | AB | 2016-09-15 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A208451-001 | ESZOPICLONE | 1MG | TABLET / ORAL | AB | 2016-09-15 | 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 | A208451-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208451-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208451-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208451-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208451-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208451-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A208451-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A208451-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A208451-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208451-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208451-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208451-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208451-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208451-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208451-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208451-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208451-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208451-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208451-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208451-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208451-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208451-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208451-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208451-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208451-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208451-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208451-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A208451-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A208451-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A208451-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208451-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208451-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208451-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A208451-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A208451-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A208451-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A208451-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A208451-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A208451-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A208451-001 | 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 |
|---|---|---|---|---|---|---|
| ESZOPICLONE | ESZOPICLONE | Preferred Pharmaceuticals, Inc. | 45558f0a-83f1-49b9-ab18-f436c0be9677 | 2026-04-13 | Boxed warning, Warnings, Adverse reactions | 208451 ANDA208451 |
| ESZOPICLONE | ESZOPICLONE | REMEDYREPACK INC. | 7df922bc-5750-4259-906f-64f960c38d5f | 2026-01-20 | Boxed warning, Warnings, Adverse reactions | 208451 ANDA208451 |
| ESZOPICLONE | ESZOPICLONE | A-S Medication Solutions | 57a8450c-59ee-4c96-bef4-308fa7b97d1e | 2025-11-07 | Boxed warning, Warnings, Adverse reactions | 208451 ANDA208451 |
| ESZOPICLONE | ESZOPICLONE | A-S Medication Solutions | bfa767ce-340b-4d3a-a9c7-0043b6d7ff6e | 2025-11-05 | Boxed warning, Warnings, Adverse reactions | 208451 ANDA208451 |
| ESZOPICLONE | ESZOPICLONE | A-S Medication Solutions | e261bf7f-1b89-4393-8c48-4e72fc29192f | 2025-11-05 | Boxed warning, Warnings, Adverse reactions | 208451 ANDA208451 |
| ESZOPICLONE | ESZOPICLONE | A-S Medication Solutions | 923cc646-f22a-4a26-88f7-a19fce016321 | 2025-11-05 | Boxed warning, Warnings, Adverse reactions | 208451 ANDA208451 |
| ESZOPICLONE | ESZOPICLONE | PD-Rx Pharmaceuticals, Inc. | bb972d36-4b2c-45ae-8504-3a16d352dd8b | 2025-10-02 | Boxed warning, Warnings, Adverse reactions | 208451 ANDA208451 |
| Eszopiclone | ESZOPICLONE | Advanced Rx of Tennessee, LLC | af869866-0a11-1a05-e053-2a95a90acdb8 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 208451 ANDA208451 |
| Eszopiclone | ESZOPICLONE | Advanced Rx of Tennessee, LLC | af86fca8-571e-0cac-e053-2a95a90ae402 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 208451 ANDA208451 |
| ESZOPICLONE | ESZOPICLONE | Bryant Ranch Prepack | 39b96725-2a01-4d9f-a56d-af7491b3b601 | 2023-11-27 | Boxed warning, Warnings, Adverse reactions | 208451 ANDA208451 |
| ESZOPICLONE | ESZOPICLONE | Proficient Rx LP | 2f4fa6e8-be82-4fb5-9a11-9ba8f557c027 | 2022-08-01 | Boxed warning, Warnings, Adverse reactions | 208451 ANDA208451 |
| ESZOPICLONE | ESZOPICLONE | Proficient Rx LP | 024f833e-c20c-46a2-971b-3f2a716b1678 | 2022-06-01 | Boxed warning, Warnings, Adverse reactions | 208451 ANDA208451 |
| ESZOPICLONE | ESZOPICLONE | Aurobindo Pharma Limited | f18cc76f-82aa-4ad7-b8ce-5737733ee104 | 2021-12-27 | Boxed warning, Warnings, Adverse reactions | 208451 ANDA208451 |
| ESZOPICLONE | ESZOPICLONE | Proficient Rx LP | bad8fe65-73c1-4542-8050-720af889905a | 2020-12-01 | Boxed warning, Warnings, Adverse reactions | 208451 ANDA208451 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 70518-3395-0 | 70518339500 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3395-0) | 2022-03-24 | 0000-00-00 | No | No | Current |