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 | Bryant Ranch Prepack | 9a891ab1-675f-498e-a21e-05964307d2dd | 2024-08-07 | Boxed warning, Warnings, Adverse reactions | ANDA202929 485465 485442 485440 UZX80K71OE |
| Eszopiclone | ESZOPICLONE | NuCarePharmaceuticals, Inc. | 53fcee89-027a-13e5-e054-00144ff8d46c | 2024-07-10 | Warnings, Adverse reactions | ANDA202929 485465 UZX80K71OE |
| Eszopiclone | ESZOPICLONE | Advanced Rx of Tennessee, LLC | 1baa56e5-34d5-c8a1-e063-6394a90ae6c7 | 2024-06-24 | Boxed warning, Warnings, Adverse reactions | 485440 UZX80K71OE |
| Eszopiclone | ESZOPICLONE | Proficient Rx LP | e32746a8-6440-4b0a-a445-4467cf0329d5 | 2024-02-01 | Boxed warning, Warnings, Adverse reactions | 485442 UZX80K71OE |
| Eszopiclone | ESZOPICLONE | Lupin Pharmaceuticals, Inc. | 7068c455-691e-4c56-9857-b7b4e13f4784 | 2024-01-17 | Boxed warning, Warnings, Adverse reactions | 485465 485442 485440 UZX80K71OE |
| ESZOPICLONE | ESZOPICLONE | Bionpharma Inc. | ec6ac172-509e-403a-aa0d-4c60010a0035 | 2023-12-01 | Boxed warning, Warnings, Adverse reactions | 485465 485442 485440 UZX80K71OE |
| ESZOPICLONE | ESZOPICLONE | Bryant Ranch Prepack | 39b96725-2a01-4d9f-a56d-af7491b3b601 | 2023-11-27 | Boxed warning, Warnings, Adverse reactions | 485440 UZX80K71OE |
| Eszopiclone | ESZOPICLONE | Golden State Medical Supply, Inc. | fef87d8d-f375-4b00-8765-957ef076bf1a | 2023-08-14 | Boxed warning, Warnings, Adverse reactions | 485465 485442 485440 UZX80K71OE |
| Eszopiclone | ESZOPICLONE | Proficient Rx LP | d301b0cf-1492-4be9-83a0-1b64c8fa3b72 | 2023-07-01 | Warnings, Adverse reactions | ANDA202929 485465 UZX80K71OE |
| Eszopiclone | ESZOPICLONE | Macleods Pharmaceuticals Limited | 12593790-e72f-45b1-8895-987cdd075134 | 2022-10-29 | Boxed warning, Warnings, Adverse reactions | ANDA202929 33342-299 485465 485442 485440 66cfec66-191e-4af9-a623-8464417fab6d 12593790-e72f-45b1-8895-987cdd075134 UZX80K71OE |
| Eszopiclone | ESZOPICLONE | Mylan Pharmaceuticals Inc. | 5469cc59-78f9-447a-9c33-12553bb4073d | 2022-10-24 | Boxed warning, Warnings, Adverse reactions | 485465 485442 485440 UZX80K71OE |
| ESZOPICLONE | ESZOPICLONE | Proficient Rx LP | 2f4fa6e8-be82-4fb5-9a11-9ba8f557c027 | 2022-08-01 | Boxed warning, Warnings, Adverse reactions | 485465 UZX80K71OE |
| Eszopiclone | ESZOPICLONE | Proficient Rx LP | ac996f97-fd92-44f8-8bb5-478a81ffb33d | 2022-07-01 | Boxed warning, Warnings, Adverse reactions | 485465 UZX80K71OE |
| Eszopiclone | ESZOPICLONE | Proficient Rx LP | 5451be60-1315-4152-ad13-412e86903c8a | 2022-07-01 | Warnings, Adverse reactions | ANDA202929 485442 UZX80K71OE |
| ESZOPICLONE | ESZOPICLONE | Proficient Rx LP | 024f833e-c20c-46a2-971b-3f2a716b1678 | 2022-06-01 | Boxed warning, Warnings, Adverse reactions | 485440 UZX80K71OE |
| Eszopiclone | ESZOPICLONE | Proficient Rx LP | edc03482-b013-448a-8cd9-2a17bd6d15e9 | 2022-05-01 | Boxed warning, Warnings, Adverse reactions | 485440 UZX80K71OE |
| ESZOPICLONE | ESZOPICLONE | Aurobindo Pharma Limited | f18cc76f-82aa-4ad7-b8ce-5737733ee104 | 2021-12-27 | Boxed warning, Warnings, Adverse reactions | 485465 485442 485440 UZX80K71OE |
| Eszopiclone | ESZOPICLONE | Teva Pharmaceuticals USA, Inc. | 2435e2f1-bc52-488f-80e9-f1758e354aae | 2021-08-01 | Boxed warning, Warnings, Adverse reactions | 485465 485442 485440 UZX80K71OE |
| ESZOPICLONE | ESZOPICLONE | Proficient Rx LP | bad8fe65-73c1-4542-8050-720af889905a | 2020-12-01 | Boxed warning, Warnings, Adverse reactions | 485442 UZX80K71OE |
| Eszopiclone | ESZOPICLONE | Aphena Pharma Solutions - Tennessee, LLC | 9bbf260f-3090-46b5-b3ef-81174697f166 | 2020-04-21 | Boxed warning, Warnings, Adverse reactions | 485465 UZX80K71OE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.