Eszopiclone
- Product NDC
- 0093-5538
- Requested package NDC
- 0093-5538-01
- 11-digit product format
- 000935538
- Labeler code
- 0093
- Product ID
- 0093-5538_359cf2e6-4461-4ebf-a542-06736029d9d0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Eszopiclone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA091169
- Marketing category
- ANDA
- Marketing start
- 2014-04-14
- Marketing end
- 0000-00-00
- Substance
- ESZOPICLONE
- Active strength
- 2 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 | 0093-5538 | 0093-5538-01 | D | Discontinued by firm | 2026-11-13 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A091169-001 | ESZOPICLONE | ESZOPICLONE | 1MG | TABLET / ORAL | AB | 2011-05-23 | |
| A091169-002 | ESZOPICLONE | ESZOPICLONE | 2MG | TABLET / ORAL | AB | 2011-05-23 | |
| A091169-003 | ESZOPICLONE | ESZOPICLONE | 3MG | TABLET / ORAL | AB | 2011-05-23 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A091169-001 | AB |
| A091169-002 | AB |
| A091169-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-11-14 07:37:17 | 2026-10 | A091169-001 | ESZOPICLONE | 1MG | TABLET / ORAL | AB | 2011-05-23 | d4dbc9d85df4… | |
| 2026-11-14 07:37:17 | 2026-10 | A091169-002 | ESZOPICLONE | 2MG | TABLET / ORAL | AB | 2011-05-23 | d4dbc9d85df4… | |
| 2026-11-14 07:37:17 | 2026-10 | A091169-003 | ESZOPICLONE | 3MG | TABLET / ORAL | AB | 2011-05-23 | d4dbc9d85df4… | |
| 2026-10-15 13:18:30 | 2026-09 | A091169-001 | ESZOPICLONE | 1MG | TABLET / ORAL | AB | 2011-05-23 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A091169-002 | ESZOPICLONE | 2MG | TABLET / ORAL | AB | 2011-05-23 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A091169-003 | ESZOPICLONE | 3MG | TABLET / ORAL | AB | 2011-05-23 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A091169-001 | ESZOPICLONE | 1MG | TABLET / ORAL | AB | 2011-05-23 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A091169-002 | ESZOPICLONE | 2MG | TABLET / ORAL | AB | 2011-05-23 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A091169-003 | ESZOPICLONE | 3MG | TABLET / ORAL | AB | 2011-05-23 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A091169-001 | ESZOPICLONE | 1MG | TABLET / ORAL | AB | 2011-05-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A091169-002 | ESZOPICLONE | 2MG | TABLET / ORAL | AB | 2011-05-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A091169-003 | ESZOPICLONE | 3MG | TABLET / ORAL | AB | 2011-05-23 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091169-001 | ESZOPICLONE | 1MG | TABLET / ORAL | AB | 2011-05-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091169-002 | ESZOPICLONE | 2MG | TABLET / ORAL | AB | 2011-05-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091169-003 | ESZOPICLONE | 3MG | TABLET / ORAL | AB | 2011-05-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091169-001 | ESZOPICLONE | 1MG | TABLET / ORAL | AB | 2011-05-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091169-002 | ESZOPICLONE | 2MG | TABLET / ORAL | AB | 2011-05-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091169-003 | ESZOPICLONE | 3MG | TABLET / ORAL | AB | 2011-05-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091169-001 | ESZOPICLONE | 1MG | TABLET / ORAL | AB | 2011-05-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091169-002 | ESZOPICLONE | 2MG | TABLET / ORAL | AB | 2011-05-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091169-003 | ESZOPICLONE | 3MG | TABLET / ORAL | AB | 2011-05-23 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091169-001 | ESZOPICLONE | 1MG | TABLET / ORAL | AB | 2011-05-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091169-002 | ESZOPICLONE | 2MG | TABLET / ORAL | AB | 2011-05-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091169-003 | ESZOPICLONE | 3MG | TABLET / ORAL | AB | 2011-05-23 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091169-001 | ESZOPICLONE | 1MG | TABLET / ORAL | AB | 2011-05-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091169-002 | ESZOPICLONE | 2MG | TABLET / ORAL | AB | 2011-05-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091169-003 | ESZOPICLONE | 3MG | TABLET / ORAL | AB | 2011-05-23 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091169-001 | ESZOPICLONE | 1MG | TABLET / ORAL | AB | 2011-05-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091169-002 | ESZOPICLONE | 2MG | TABLET / ORAL | AB | 2011-05-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091169-003 | ESZOPICLONE | 3MG | TABLET / ORAL | AB | 2011-05-23 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091169-001 | ESZOPICLONE | 1MG | TABLET / ORAL | AB | 2011-05-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091169-002 | ESZOPICLONE | 2MG | TABLET / ORAL | AB | 2011-05-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091169-003 | ESZOPICLONE | 3MG | TABLET / ORAL | AB | 2011-05-23 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091169-001 | ESZOPICLONE | 1MG | TABLET / ORAL | AB | 2011-05-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091169-002 | ESZOPICLONE | 2MG | TABLET / ORAL | AB | 2011-05-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091169-003 | ESZOPICLONE | 3MG | TABLET / ORAL | AB | 2011-05-23 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091169-001 | ESZOPICLONE | 1MG | TABLET / ORAL | AB | 2011-05-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091169-002 | ESZOPICLONE | 2MG | TABLET / ORAL | AB | 2011-05-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091169-003 | ESZOPICLONE | 3MG | TABLET / ORAL | AB | 2011-05-23 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091169-001 | ESZOPICLONE | 1MG | TABLET / ORAL | AB | 2011-05-23 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-11-14 07:37:17 | 2026-10 | A091169-001 | AB | 1 | d4dbc9d85df4… |
| 2026-11-14 07:37:17 | 2026-10 | A091169-002 | AB | 1 | d4dbc9d85df4… |
| 2026-11-14 07:37:17 | 2026-10 | A091169-003 | AB | 1 | d4dbc9d85df4… |
| 2026-10-15 13:18:30 | 2026-09 | A091169-001 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A091169-002 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A091169-003 | AB | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A091169-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A091169-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A091169-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A091169-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A091169-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A091169-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A091169-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091169-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091169-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091169-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091169-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091169-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A091169-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091169-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091169-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091169-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091169-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091169-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091169-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091169-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091169-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091169-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091169-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091169-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091169-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091169-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091169-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091169-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091169-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091169-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091169-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091169-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091169-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A091169-001 | AB | 1 | d06236e962d9… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f65008ed-f925-2246-581a-e6a3201df7e4 | Product name | 5 | 20250107 |
| 351abe41-466c-4dd8-840a-0fdb68318bd5 | Product name | 1 | 20230316 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0093-5538-01 | Eszopiclone | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 17 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0093-5538-01 | EA - Each | 0093-5538 | 2b45db4b-a511-4f0e-942e-29b7e4dfa57e | 1 | 2014-05-02 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 | Teva Pharmaceuticals USA, Inc. | 2435e2f1-bc52-488f-80e9-f1758e354aae | 2021-08-01 | Boxed warning, Warnings, Adverse reactions | 091169 ANDA091169 0093-5538-01 0093-5538 00093553801 |
| Eszopiclone | ESZOPICLONE | Aphena Pharma Solutions - Tennessee, LLC | 9bbf260f-3090-46b5-b3ef-81174697f166 | 2020-04-21 | Boxed warning, Warnings, Adverse reactions | 091169 ANDA091169 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 485440 | eszopiclone 1 MG Oral Tablet | PSN | 2435e2f1-bc52-488f-80e9-f1758e354aae | 17 |
| 485442 | eszopiclone 2 MG Oral Tablet | PSN | 2435e2f1-bc52-488f-80e9-f1758e354aae | 17 |
| 485465 | eszopiclone 3 MG Oral Tablet | PSN | 2435e2f1-bc52-488f-80e9-f1758e354aae | 17 |
| 485440 | eszopiclone 1 MG Oral Tablet | SCD | 2435e2f1-bc52-488f-80e9-f1758e354aae | 17 |
| 485442 | eszopiclone 2 MG Oral Tablet | SCD | 2435e2f1-bc52-488f-80e9-f1758e354aae | 17 |
| 485465 | eszopiclone 3 MG Oral Tablet | SCD | 2435e2f1-bc52-488f-80e9-f1758e354aae | 17 |
| 485442 | eszopiclone 2 MG Oral Tablet | PSN | 48925d07-1e06-4761-bbdc-d8b7e70ad155 | 11 |
| 485465 | eszopiclone 3 MG Oral Tablet | PSN | 48925d07-1e06-4761-bbdc-d8b7e70ad155 | 11 |
| 485442 | eszopiclone 2 MG Oral Tablet | SCD | 48925d07-1e06-4761-bbdc-d8b7e70ad155 | 11 |
| 485465 | eszopiclone 3 MG Oral Tablet | SCD | 48925d07-1e06-4761-bbdc-d8b7e70ad155 | 11 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0093-5538-01 | 00093553801 | 100 TABLET, FILM COATED in 1 BOTTLE (0093-5538-01) | 2014-04-14 | 0000-00-00 | No | No | Current |