NDC 80425-0168-01 - Eszopiclone
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 80425-0168
- Requested NDC
- 80425-0168-01
- Package NDCs from labels
- 80425-0168-2, 80425-0168-3, 80425-0168-1, 80425-0168-01
- Manufacturer
- Advanced Rx Pharmacy of Tennessee, LLC
- Effective date
- 2024-12-31
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Eszopiclone - Advanced Rx Pharmacy of Tennessee, LLC | Advanced Rx Pharmacy of Tennessee, LLC | 2024-12-31 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80425-0168-1 | Eszopiclone | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 7 | |
| 80425-0168-2 | Eszopiclone | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | 7 | |
| 80425-0168-3 | Eszopiclone | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 7 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80425-0168 | ESZOPICLONE TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 7 | Current NDC, Legacy NDC, 3 package rows | 20250101_c8ae09eb-4c9b-4560-e053-2995a90a02b1.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80425-0168-1 | EA - Each | 80425-0168 | b51d59ea-3e6c-44b9-a464-b840240f98bb | 1 | 2023-06-06 |
| 80425-0168-2 | EA - Each | 80425-0168 | 8b4fba70-0cf7-42d9-88b0-ae4d5b110f5c | 1 | 2023-04-07 |
| 80425-0168-3 | EA - Each | 80425-0168 | 6f4105d9-6c2d-4562-ae8a-8a80673c2be2 | 1 | 2023-06-06 |
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 | PD-Rx Pharmaceuticals, Inc. | bb972d36-4b2c-45ae-8504-3a16d352dd8b | 2025-10-02 | Boxed warning, Warnings, Adverse reactions | 485465 UZX80K71OE |
| Eszopiclone | ESZOPICLONE | Bryant Ranch Prepack | f6022b2f-9b43-40cc-91c7-c224b209efab | 2025-09-24 | Boxed warning, Warnings, Adverse reactions | ANDA202929 485442 UZX80K71OE |
| Eszopiclone | ESZOPICLONE | Camber Pharmaceuticals, Inc. | 00fc3250-3e29-4a4b-ac0c-74910659337c | 2025-02-20 | Boxed warning, Warnings, Adverse reactions | 485465 485442 485440 UZX80K71OE |
| Eszopiclone | ESZOPICLONE | Asclemed USA, Inc. | 10175591-c1b4-461a-830e-8df982d0d2bf | 2025-02-12 | Boxed warning, Warnings, Adverse reactions | ANDA202929 485465 485442 485440 UZX80K71OE |
| Eszopiclone | ESZOPICLONE | Preferred Pharmaceuticals Inc. | be25bb4e-d84f-4396-a78f-a668a207cf2d | 2025-02-10 | Boxed warning, Warnings, Adverse reactions | ANDA202929 485440 UZX80K71OE |
| ESZOPICLONE | ESZOPICLONE | DIRECT RX | a7bd3e3c-26e9-07e7-e053-2995a90a9ca5 | 2025-01-17 | Boxed warning, Adverse reactions | 485440 UZX80K71OE |
| Lunesta | ESZOPICLONE | Waylis Therapeutics LLC | 3821f4b7-a3c8-4920-ba80-18aa96532c09 | 2025-01-08 | Boxed warning, Warnings, Adverse reactions | 485465 485442 485440 UZX80K71OE |
| Eszopiclone | ESZOPICLONE | Advanced Rx of Tennessee, LLC | af86fca8-571a-0cac-e053-2a95a90ae402 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | ANDA202929 485442 UZX80K71OE |
| Eszopiclone | ESZOPICLONE | Advanced Rx of Tennessee, LLC | af863d89-25db-2893-e053-2a95a90a704c | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | ANDA202929 485465 UZX80K71OE |
| Eszopiclone | ESZOPICLONE | Advanced Rx of Tennessee, LLC | af86ebdb-e47b-706a-e053-2995a90ad51c | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 485442 UZX80K71OE |
| Eszopiclone | ESZOPICLONE | Advanced Rx of Tennessee, LLC | af869866-0a11-1a05-e053-2a95a90acdb8 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 485465 UZX80K71OE |
| Eszopiclone | ESZOPICLONE | Advanced Rx of Tennessee, LLC | af86b753-d2ee-9b5f-e053-2a95a90ad23d | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 485465 UZX80K71OE |
| Eszopiclone | ESZOPICLONE | Advanced Rx of Tennessee, LLC | af86fca8-571e-0cac-e053-2a95a90ae402 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 485442 UZX80K71OE |
| Eszopiclone | ESZOPICLONE | Advanced Rx of Tennessee, LLC | b39dc64d-adc9-742e-e053-2a95a90ad18b | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 485440 UZX80K71OE |
| Eszopiclone | ESZOPICLONE | Advanced Rx Pharmacy of Tennessee, LLC | b4f272eb-02e3-415a-e053-2a95a90a428f | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 485465 UZX80K71OE |
| Eszopiclone | ESZOPICLONE | Advanced Rx Pharmacy of Tennessee, LLC | c8ae09eb-4c9b-4560-e053-2995a90a02b1 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | ANDA202929 80425-0168-3 80425-0168-2 80425-0168-1 80425-0168 80425016801 485440 2a99e9e8-3d16-ee0b-e063-6294a90ae4ef c8ae09eb-4c9b-4560-e053-2995a90a02b1 UZX80K71OE |
| Eszopiclone | ESZOPICLONE | Dr. Reddy's Laboratories Limited | 0b363b90-93dc-1fc1-0501-d140dfc762c7 | 2024-12-19 | Boxed warning, Warnings, Adverse reactions | 485465 485442 485440 UZX80K71OE |
| Eszopiclone | ESZOPICLONE | Quality Care Products LLC | 3b8a09c6-0702-43a7-b47f-a36cd00b7584 | 2024-12-17 | Warnings, Adverse reactions | ANDA202929 485465 UZX80K71OE |
| Eszopiclone | ESZOPICLONE | Quality Care Products LLC | 7832f554-2b82-4ef2-b1ef-266179f271d3 | 2024-12-17 | Warnings, Adverse reactions | ANDA202929 485442 UZX80K71OE |
| Eszopiclone | ESZOPICLONE | Bryant Ranch Prepack | d1baa5ba-73ac-462b-a728-217d5992674a | 2024-08-23 | Boxed warning, Warnings, Adverse reactions | 485442 485440 UZX80K71OE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.