NDC 80425-0295-01 - Temazepam
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
- 80425-0295
- Requested NDC
- 80425-0295-01
- Package NDCs from labels
- 80425-0295-1, 80425-0295-2, 80425-0295-3, 80425-0295-01
- 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 |
|---|---|---|---|
| Temazepam - 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 |
|---|---|---|---|---|---|---|
| 80425-0295-1 | Temazepam | 30 in 1 BOTTLE | CAPSULE | 30 | 2 | |
| 80425-0295-2 | Temazepam | 60 in 1 BOTTLE | CAPSULE | 60 | 2 | |
| 80425-0295-3 | Temazepam | 90 in 1 BOTTLE | CAPSULE | 90 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80425-0295 | TEMAZEPAM CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 2 | Current NDC, 3 package rows | 20250102_f885bb1a-0445-c452-e053-6394a90ae8aa.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80425-0295-1 | EA - Each | 80425-0295 | 34ddee73-0dfb-422f-b27d-0e88531e071a | 1 | 2023-06-06 |
| 80425-0295-2 | EA - Each | 80425-0295 | ff7ce65a-7415-4125-92f4-dd67ef9f8615 | 1 | 2023-06-06 |
| 80425-0295-3 | EA - Each | 80425-0295 | e17e0465-1803-46d9-93ee-8d48486c8a30 | 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 |
|---|---|---|---|---|---|---|
| temazepam | TEMAZEPAM | Aphena Pharma Solutions - Tennessee, LLC | b2422ca0-2f06-419f-aa0e-88c556b62399 | 2024-01-23 | Boxed warning, Warnings, Adverse reactions | ANDA071456 ANDA071457 198242 198241 CHB1QD2QSS |
| temazepam | TEMAZEPAM | Bryant Ranch Prepack | 1e37d59b-b8be-46ef-8706-fffd563a8c15 | 2024-01-11 | Boxed warning, Warnings, Adverse reactions | ANDA071457 485489 CHB1QD2QSS |
| temazepam | TEMAZEPAM | Bryant Ranch Prepack | 0e752dda-f00f-4123-b59f-aa911b897a5a | 2023-12-01 | Boxed warning, Warnings, Adverse reactions | ANDA071457 198242 CHB1QD2QSS |
| Temazepam | TEMAZEPAM | Bryant Ranch Prepack | 74a3db09-94d0-45e1-8c68-da7ca49d3d59 | 2023-11-22 | Boxed warning, Warnings, Adverse reactions | 485489 CHB1QD2QSS |
| temazepam | TEMAZEPAM | Bryant Ranch Prepack | 4ae0c582-8b0f-42f9-9b05-f7e1698c5183 | 2023-11-03 | Boxed warning, Warnings, Adverse reactions | ANDA071457 198242 CHB1QD2QSS |
| temazepam | TEMAZEPAM | Bryant Ranch Prepack | 5dc0c671-3cd8-4e75-9e76-19c1c17b30b2 | 2023-11-03 | Boxed warning, Warnings, Adverse reactions | ANDA071456 198241 CHB1QD2QSS |
| temazepam | TEMAZEPAM | Proficient Rx LP | 904b8986-24da-48eb-bb0a-33d41b4eb005 | 2023-06-01 | Warnings, Adverse reactions | ANDA071456 198241 CHB1QD2QSS |
| Temazepam | TEMAZEPAM | Alembic Pharmaceuticals Inc. | 93b1be7f-ec41-46bb-a258-56cb459e2c92 | 2023-02-20 | Boxed warning, Warnings, Adverse reactions | 485489 198243 198242 198241 CHB1QD2QSS |
| Temazepam | TEMAZEPAM | Alembic Pharmaceuticals Limited | db839409-8e95-41d3-804e-dcd5d11f4934 | 2023-01-27 | Boxed warning, Warnings, Adverse reactions | 485489 198243 198242 198241 CHB1QD2QSS |
| temazepam | TEMAZEPAM | Proficient Rx LP | ccf04879-3ad5-4fc3-89f5-879c97887017 | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | ANDA071456 ANDA071457 198242 198241 CHB1QD2QSS |
| temazepam | TEMAZEPAM | Proficient Rx LP | 5aaf8c99-cd58-47fc-8bf5-1039a6315ca5 | 2021-01-01 | Warnings, Adverse reactions | ANDA071457 198242 CHB1QD2QSS |
| Temazepam | TEMAZEPAM | Aphena Pharma Solutions - Tennessee, LLC | 2461dfbd-5704-42f4-bde7-d1461811d898 | 2019-05-17 | Warnings, Adverse reactions | 198242 198241 CHB1QD2QSS |
| TEMAZEPAM | TEMAZEPAM | Aphena Pharma Solutions - Tennessee, LLC | 405b1ee2-777b-4fd3-b4ee-bd2aacbe1dc1 | 2019-03-26 | Boxed warning, Warnings, Adverse reactions | 198243 CHB1QD2QSS |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.