Eszopiclone
- Product NDC
- 68788-6953
- Requested package NDC
- 68788-6953-1
- 11-digit product format
- 687886953
- Labeler code
- 68788
- Product ID
- 68788-6953_10ead623-c81b-4ff1-9079-7c53e5ba2555
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Eszopiclone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA202929
- Marketing category
- ANDA
- Marketing start
- 2017-05-01
- Marketing end
- 0000-00-00
- Substance
- ESZOPICLONE
- Active strength
- 1 mg/1
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 | 68788-6953 | 68788-6953-1 | 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 | 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 |
|---|---|---|---|---|---|---|---|
| A202929-001 | ESZOPICLONE | ESZOPICLONE | 1MG | TABLET / ORAL | AB | 2015-01-30 | |
| A202929-002 | ESZOPICLONE | ESZOPICLONE | 2MG | TABLET / ORAL | AB | 2015-01-30 | |
| A202929-003 | ESZOPICLONE | ESZOPICLONE | 3MG | TABLET / ORAL | AB | 2015-01-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A202929-001 | AB |
| A202929-002 | AB |
| A202929-003 | 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 | A202929-001 | ESZOPICLONE | 1MG | TABLET / ORAL | AB | 2015-01-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202929-002 | ESZOPICLONE | 2MG | TABLET / ORAL | AB | 2015-01-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202929-003 | ESZOPICLONE | 3MG | TABLET / ORAL | AB | 2015-01-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202929-001 | ESZOPICLONE | 1MG | TABLET / ORAL | AB | 2015-01-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202929-002 | ESZOPICLONE | 2MG | TABLET / ORAL | AB | 2015-01-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202929-003 | ESZOPICLONE | 3MG | TABLET / ORAL | AB | 2015-01-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202929-001 | ESZOPICLONE | 1MG | TABLET / ORAL | AB | 2015-01-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202929-002 | ESZOPICLONE | 2MG | TABLET / ORAL | AB | 2015-01-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202929-003 | ESZOPICLONE | 3MG | TABLET / ORAL | AB | 2015-01-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202929-001 | ESZOPICLONE | 1MG | TABLET / ORAL | AB | 2015-01-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202929-002 | ESZOPICLONE | 2MG | TABLET / ORAL | AB | 2015-01-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202929-003 | ESZOPICLONE | 3MG | TABLET / ORAL | AB | 2015-01-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202929-001 | ESZOPICLONE | 1MG | TABLET / ORAL | AB | 2015-01-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202929-002 | ESZOPICLONE | 2MG | TABLET / ORAL | AB | 2015-01-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202929-003 | ESZOPICLONE | 3MG | TABLET / ORAL | AB | 2015-01-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202929-001 | ESZOPICLONE | 1MG | TABLET / ORAL | AB | 2015-01-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202929-002 | ESZOPICLONE | 2MG | TABLET / ORAL | AB | 2015-01-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202929-003 | ESZOPICLONE | 3MG | TABLET / ORAL | AB | 2015-01-30 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202929-001 | ESZOPICLONE | 1MG | TABLET / ORAL | AB | 2015-01-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202929-002 | ESZOPICLONE | 2MG | TABLET / ORAL | AB | 2015-01-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202929-003 | ESZOPICLONE | 3MG | TABLET / ORAL | AB | 2015-01-30 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202929-001 | ESZOPICLONE | 1MG | TABLET / ORAL | AB | 2015-01-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202929-002 | ESZOPICLONE | 2MG | TABLET / ORAL | AB | 2015-01-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202929-003 | ESZOPICLONE | 3MG | TABLET / ORAL | AB | 2015-01-30 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202929-001 | ESZOPICLONE | 1MG | TABLET / ORAL | AB | 2015-01-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202929-002 | ESZOPICLONE | 2MG | TABLET / ORAL | AB | 2015-01-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202929-003 | ESZOPICLONE | 3MG | TABLET / ORAL | AB | 2015-01-30 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202929-001 | ESZOPICLONE | 1MG | TABLET / ORAL | AB | 2015-01-30 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202929-002 | ESZOPICLONE | 2MG | TABLET / ORAL | AB | 2015-01-30 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202929-003 | ESZOPICLONE | 3MG | TABLET / ORAL | AB | 2015-01-30 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202929-001 | ESZOPICLONE | 1MG | TABLET / ORAL | AB | 2015-01-30 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202929-002 | ESZOPICLONE | 2MG | TABLET / ORAL | AB | 2015-01-30 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202929-003 | ESZOPICLONE | 3MG | TABLET / ORAL | AB | 2015-01-30 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202929-001 | ESZOPICLONE | 1MG | TABLET / ORAL | AB | 2015-01-30 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202929-002 | ESZOPICLONE | 2MG | TABLET / ORAL | AB | 2015-01-30 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202929-003 | ESZOPICLONE | 3MG | TABLET / ORAL | AB | 2015-01-30 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202929-001 | ESZOPICLONE | 1MG | TABLET / ORAL | AB | 2015-01-30 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202929-002 | ESZOPICLONE | 2MG | TABLET / ORAL | AB | 2015-01-30 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202929-003 | ESZOPICLONE | 3MG | TABLET / ORAL | AB | 2015-01-30 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A202929-001 | ESZOPICLONE | 1MG | TABLET / ORAL | AB | 2015-01-30 | 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 | A202929-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202929-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202929-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202929-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202929-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202929-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202929-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202929-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202929-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202929-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202929-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202929-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202929-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202929-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202929-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202929-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202929-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202929-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202929-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202929-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202929-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202929-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202929-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202929-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202929-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202929-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202929-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A202929-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A202929-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A202929-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202929-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202929-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202929-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202929-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202929-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202929-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202929-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202929-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202929-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A202929-001 | 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. | 2b5b4fbb-9b86-46c6-9508-37d3d9806dec | 2026-04-14 | Boxed warning, Warnings, Adverse reactions | 202929 ANDA202929 |
| Eszopiclone | ESZOPICLONE | REMEDYREPACK INC. | 61fd4655-060f-4393-a610-019d8b127058 | 2026-04-13 | Boxed warning, Warnings, Adverse reactions | 202929 ANDA202929 |
| Eszopiclone | ESZOPICLONE | Preferred Pharmaceuticals Inc. | abe3a610-a25d-4b52-8537-c87e8ba3104a | 2026-04-13 | Boxed warning, Warnings, Adverse reactions | 202929 ANDA202929 |
| ESZOPICLONE | ESZOPICLONE | DIRECT RX | 486b760b-7fea-306b-e054-00144ff8d46c | 2026-03-05 | Warnings, Adverse reactions | 202929 ANDA202929 |
| Eszopiclone | ESZOPICLONE | Bryant Ranch Prepack | f6022b2f-9b43-40cc-91c7-c224b209efab | 2025-09-24 | Boxed warning, Warnings, Adverse reactions | 202929 ANDA202929 |
| Eszopiclone | ESZOPICLONE | REMEDYREPACK INC. | 9dfe774a-2c7a-4e10-bedd-cde64ad28676 | 2025-07-24 | Boxed warning, Warnings, Adverse reactions | 202929 ANDA202929 |
| Eszopiclone | ESZOPICLONE | Asclemed USA, Inc. | 10175591-c1b4-461a-830e-8df982d0d2bf | 2025-02-12 | Boxed warning, Warnings, Adverse reactions | 202929 ANDA202929 |
| Eszopiclone | ESZOPICLONE | Preferred Pharmaceuticals Inc. | be25bb4e-d84f-4396-a78f-a668a207cf2d | 2025-02-10 | Boxed warning, Warnings, Adverse reactions | 202929 ANDA202929 |
| Eszopiclone | ESZOPICLONE | Advanced Rx of Tennessee, LLC | af86fca8-571a-0cac-e053-2a95a90ae402 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 202929 ANDA202929 |
| Eszopiclone | ESZOPICLONE | Advanced Rx of Tennessee, LLC | af863d89-25db-2893-e053-2a95a90a704c | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 202929 ANDA202929 |
| Eszopiclone | ESZOPICLONE | Advanced Rx Pharmacy of Tennessee, LLC | c8ae09eb-4c9b-4560-e053-2995a90a02b1 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 202929 ANDA202929 |
| Eszopiclone | ESZOPICLONE | Lake Erie Medical DBA Quality Care Products LLC | 9460be93-cd53-4429-a4d9-2f04e3835168 | 2024-12-18 | Warnings, Adverse reactions | 202929 ANDA202929 |
| Eszopiclone | ESZOPICLONE | Quality Care Products LLC | 3b8a09c6-0702-43a7-b47f-a36cd00b7584 | 2024-12-17 | Warnings, Adverse reactions | 202929 ANDA202929 |
| Eszopiclone | ESZOPICLONE | Quality Care Products LLC | 7832f554-2b82-4ef2-b1ef-266179f271d3 | 2024-12-17 | Warnings, Adverse reactions | 202929 ANDA202929 |
| Eszopiclone | ESZOPICLONE | Bryant Ranch Prepack | 9a891ab1-675f-498e-a21e-05964307d2dd | 2024-08-07 | Boxed warning, Warnings, Adverse reactions | 202929 ANDA202929 |
| Eszopiclone | ESZOPICLONE | NuCarePharmaceuticals, Inc. | 53fcee89-027a-13e5-e054-00144ff8d46c | 2024-07-10 | Warnings, Adverse reactions | 202929 ANDA202929 |
| Eszopiclone | ESZOPICLONE | Proficient Rx LP | d301b0cf-1492-4be9-83a0-1b64c8fa3b72 | 2023-07-01 | Warnings, Adverse reactions | 202929 ANDA202929 |
| Eszopiclone | ESZOPICLONE | Macleods Pharmaceuticals Limited | 12593790-e72f-45b1-8895-987cdd075134 | 2022-10-29 | Boxed warning, Warnings, Adverse reactions | 202929 ANDA202929 |
| Eszopiclone | ESZOPICLONE | Proficient Rx LP | 5451be60-1315-4152-ad13-412e86903c8a | 2022-07-01 | Warnings, Adverse reactions | 202929 ANDA202929 |
| Eszopiclone | ESZOPICLONE | Proficient Rx LP | 1582ba77-a4e3-464f-876b-28cc7e41e8f1 | 2020-02-01 | Warnings, Adverse reactions | 202929 ANDA202929 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68788-6953-1 | 68788695301 | 10 TABLET, FILM COATED in 1 BOTTLE (68788-6953-1) | 2017-05-01 | 0000-00-00 | No | No | Current |