NDC 80425-0295-03 - 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
- 80425-0295-03
- Package NDCs from labels
- 80425-0295-1, 80425-0295-2, 80425-0295-3, 80425-0295-03
- 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 | Bryant Ranch Prepack | ac08a51c-6c54-40da-9626-a4c82f337a3a | 2026-09-09 | Boxed warning, Warnings, Adverse reactions | ANDA071456 198241 CHB1QD2QSS |
| temazepam | TEMAZEPAM | Bryant Ranch Prepack | 5d83e474-0932-49ae-ad92-ca278cd5f1d5 | 2026-09-09 | Boxed warning, Warnings, Adverse reactions | ANDA071457 198242 CHB1QD2QSS |
| temazepam | TEMAZEPAM | Bryant Ranch Prepack | 1c08d30d-7c27-a09a-5240-7050771d5cc7 | 2026-09-08 | Boxed warning, Warnings, Adverse reactions | ANDA071457 198242 CHB1QD2QSS |
| Temazepam | TEMAZEPAM | Major Pharmaceuticals | 2c4f564d-d349-4f9b-b3f4-f3f0d9706a4d | 2026-09-01 | Boxed warning, Warnings, Adverse reactions | ANDA071457 198243 CHB1QD2QSS |
| temazepam | TEMAZEPAM | PD-Rx Pharmaceuticals, Inc. | 62379cd5-a314-43eb-a1ee-33997623bfa3 | 2026-08-10 | Warnings, Adverse reactions | ANDA071457 198242 CHB1QD2QSS |
| temazepam | TEMAZEPAM | Ascend Laboratories, LLC | 8f54731f-c5b7-492c-acb0-444c5fbb7029 | 2026-08-05 | Boxed warning, Warnings, Adverse reactions | ANDA071456 ANDA071457 67877-147 485489 198243 198242 198241 23e08cbc-80d4-4938-8d56-10e7682b5336 8f54731f-c5b7-492c-acb0-444c5fbb7029 CHB1QD2QSS |
| Temazepam | TEMAZEPAM | REMEDYREPACK INC. | 85919240-0bac-4ed9-97aa-f1aa29be7ffa | 2026-07-24 | Boxed warning, Warnings, Adverse reactions | 198241 CHB1QD2QSS |
| RESTORIL | TEMAZEPAM | SpecGx LLC | bc56f7fd-1aaf-48ff-8aa7-d467e59e1015 | 2026-06-09 | Boxed warning, Warnings, Adverse reactions | 485489 198243 198242 198241 CHB1QD2QSS |
| TEMAZEPAM | TEMAZEPAM | SpecGx LLC | c9bc61b4-a579-4003-98da-b6f6e381c150 | 2026-06-04 | Boxed warning, Warnings, Adverse reactions | 485489 198243 198242 198241 CHB1QD2QSS |
| Temazepam | TEMAZEPAM | Aphena Pharma Solutions - Tennessee, LLC | 4a2ab77d-8b80-7eb1-e063-6394a90a1469 | 2026-02-09 | Boxed warning, Warnings, Adverse reactions | 198242 CHB1QD2QSS |
| temazepam | TEMAZEPAM | Preferred Pharmaceuticals Inc. | 7e3fd8fe-fb8a-4577-b540-0e3fefe63627 | 2026-01-14 | Boxed warning, Warnings, Adverse reactions | ANDA071457 198242 CHB1QD2QSS |
| Temazepam | TEMAZEPAM | American Health Packaging | a3f06243-fa03-4cbd-951a-144ec43dcdfd | 2025-11-13 | Boxed warning, Warnings, Adverse reactions | 198243 CHB1QD2QSS |
| temazepam | TEMAZEPAM | Bryant Ranch Prepack | 4fe8192a-0f65-4958-8b6d-e87b9fae9eb5 | 2025-11-06 | Boxed warning, Warnings, Adverse reactions | ANDA071457 198242 CHB1QD2QSS |
| temazepam | TEMAZEPAM | Bryant Ranch Prepack | bbb6e233-dc6b-43a7-8203-d91421d89921 | 2025-11-06 | Boxed warning, Warnings, Adverse reactions | ANDA071457 198242 CHB1QD2QSS |
| temazepam | TEMAZEPAM | Bryant Ranch Prepack | a1f0ed55-9401-4afe-ba98-1ca115ba86b5 | 2025-11-06 | Boxed warning, Warnings, Adverse reactions | ANDA071456 198241 CHB1QD2QSS |
| temazepam | TEMAZEPAM | A-S Medication Solutions | 19b2711e-587a-47d2-ab62-d564e7b87195 | 2025-10-27 | Boxed warning, Warnings, Adverse reactions | ANDA071456 ANDA071457 198242 198241 CHB1QD2QSS |
| temazepam | TEMAZEPAM | PD-Rx Pharmaceuticals, Inc. | 45ef5e9c-f381-48d3-895d-e1d29be856ac | 2025-10-20 | Boxed warning, Warnings, Adverse reactions | ANDA071456 198241 CHB1QD2QSS |
| TEMAZEPAM | TEMAZEPAM | PD-Rx Pharmaceuticals, Inc. | 97afda58-4daf-4192-bd87-3ccbb000ee52 | 2025-10-14 | Boxed warning, Warnings, Adverse reactions | 198242 CHB1QD2QSS |
| temazepam | TEMAZEPAM | Bryant Ranch Prepack | dadc2f66-7fa5-4be4-a9d0-d96e5836f550 | 2025-10-09 | Boxed warning, Warnings, Adverse reactions | ANDA071457 485489 CHB1QD2QSS |
| temazepam | TEMAZEPAM | Asclemed USA, Inc. | 254a0273-c0f3-4d2d-b18e-4ab51ba4bc50 | 2025-10-08 | Boxed warning, Warnings, Adverse reactions | ANDA071456 ANDA071457 485489 198243 198242 198241 CHB1QD2QSS |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.