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 | Proficient Rx LP | 1582ba77-a4e3-464f-876b-28cc7e41e8f1 | 2020-02-01 | Warnings, Adverse reactions | ANDA202929 485440 UZX80K71OE |
| ESZOPICLONE | ESZOPICLONE | Sun Pharmaceutical Industries, Inc. | 8bb1965e-7845-4c5b-b021-38e251303d68 | 2018-10-25 | Warnings, Adverse reactions | 485465 485442 485440 UZX80K71OE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.