NDC 80425-0191-01 - 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
- 80425-0191
- Requested NDC
- 80425-0191-01
- Package NDCs from labels
- 80425-0191-1, 80425-0191-2, 80425-0191-01
- 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 |
|---|---|---|---|---|---|---|
| 80425-0191-1 | Temazepam | 20 in 1 BOTTLE | CAPSULE | 20 | 5 | |
| 80425-0191-2 | Temazepam | 30 in 1 BOTTLE | CAPSULE | 30 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80425-0191 | TEMAZEPAM CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20250101_d83e14ae-9823-e57b-e053-2a95a90a8524.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80425-0191-1 | EA - Each | 80425-0191 | 962604b0-87a8-4ea5-80c1-7b0b03cdf45a | 1 | 2023-06-06 |
| 80425-0191-2 | EA - Each | 80425-0191 | 61a91cb3-0736-4380-a334-350db2f01a98 | 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 | 38afa73c-7c87-440d-bece-f268e8e4a44c | 2025-03-28 | Boxed warning, Warnings, Adverse reactions | 198241 CHB1QD2QSS |
| temazepam | TEMAZEPAM | AvPAK | 08183adb-af12-fcb2-e063-6394a90afea4 | 2025-01-09 | Boxed warning, Warnings, Adverse reactions | ANDA071456 198242 198241 CHB1QD2QSS |
| Temazepam | TEMAZEPAM | Actavis Pharma, Inc. | a4370eb4-b00d-4247-af8d-980e59fbbec6 | 2025-01-01 | Boxed warning, Warnings, Adverse reactions | 198242 198241 CHB1QD2QSS |
| Temazepam | TEMAZEPAM | Advanced Rx Pharmacy of Tennessee, LLC | d83e14ae-9823-e57b-e053-2a95a90a8524 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | ANDA071456 80425-0191-1 80425-0191-2 80425-0191 80425019101 198241 2a99a670-af37-299d-e063-6294a90a05d2 d83e14ae-9823-e57b-e053-2a95a90a8524 CHB1QD2QSS |
| Temazepam | TEMAZEPAM | Advanced Rx Pharmacy of Tennessee, LLC | f885bb1a-0445-c452-e053-6394a90ae8aa | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | ANDA071456 198242 CHB1QD2QSS |
| Temazepam | TEMAZEPAM | Bryant Ranch Prepack | 066e25b2-8a1b-4b08-b585-ce36753bf104 | 2024-12-11 | Boxed warning, Warnings, Adverse reactions | 198242 CHB1QD2QSS |
| temazepam | TEMAZEPAM | Bryant Ranch Prepack | ed068e02-a9c6-41ce-beca-83762720663d | 2024-11-01 | Boxed warning, Warnings, Adverse reactions | 198242 CHB1QD2QSS |
| Temazepam | TEMAZEPAM | Amneal Pharmaceuticals LLC | be68c6e0-17ad-40fe-9bc1-58abe24b53f6 | 2024-10-30 | Boxed warning, Warnings, Adverse reactions | 485489 198243 198242 198241 CHB1QD2QSS |
| temazepam | TEMAZEPAM | Bryant Ranch Prepack | 8af67441-167f-4cc8-a498-c4377ba41c6d | 2024-08-30 | Boxed warning, Warnings, Adverse reactions | 198242 CHB1QD2QSS |
| Temazepam | TEMAZEPAM | Bryant Ranch Prepack | 44461dcc-5c1e-4852-92d3-854ac0849e3d | 2024-08-29 | Boxed warning, Warnings, Adverse reactions | 198241 CHB1QD2QSS |
| temazepam | TEMAZEPAM | NuCare Pharmaceuticals,Inc. | 62fc08cd-8143-1652-e053-2a91aa0ad7ed | 2024-08-14 | Warnings, Adverse reactions | 198242 CHB1QD2QSS |
| Temazepam | TEMAZEPAM | Solco Healthcare U.S., LLC | 3ce42f0e-821e-4c9a-8f6b-60621628fd4b | 2024-07-25 | Boxed warning, Warnings, Adverse reactions | 485489 198243 198242 198241 CHB1QD2QSS |
| Temazepam | TEMAZEPAM | Golden State Medical Supply, Inc. | 1ddc31b7-2b23-fb10-e063-6394a90a55f3 | 2024-07-22 | Boxed warning, Warnings, Adverse reactions | 198242 198241 CHB1QD2QSS |
| Temazepam | TEMAZEPAM CIV | NuCare Pharmaceuticals,Inc. | 617d1957-c414-7f34-e053-2a91aa0a3fe0 | 2024-07-18 | Boxed warning, Warnings, Adverse reactions | 198242 CHB1QD2QSS |
| TEMAZEPAM | TEMAZEPAM | Aphena Pharma Solutions - Tennessee, LLC | a8deb28b-c5a3-4775-8bec-3f276698d064 | 2024-06-18 | Boxed warning, Warnings, Adverse reactions | 198242 198241 CHB1QD2QSS |
| temazepam | TEMAZEPAM | Bryant Ranch Prepack | a90d9165-da54-48e5-b144-ebeb6ff8d8ab | 2024-05-31 | Boxed warning, Warnings, Adverse reactions | ANDA071456 198241 CHB1QD2QSS |
| temazepam | TEMAZEPAM | Bryant Ranch Prepack | 6559dfee-c29b-4707-8b30-8ca14bf23ea0 | 2024-03-22 | Boxed warning, Warnings, Adverse reactions | 198243 CHB1QD2QSS |
| temazepam | TEMAZEPAM | Bryant Ranch Prepack | 432252c6-648f-4c53-976c-ee271ba435bd | 2024-03-07 | Boxed warning, Warnings, Adverse reactions | ANDA071456 198241 CHB1QD2QSS |
| temazepam | TEMAZEPAM | Bryant Ranch Prepack | 147a51d7-2f8d-43e8-b0ed-a79a2cdfc0a9 | 2024-03-06 | Boxed warning, Warnings, Adverse reactions | 198243 CHB1QD2QSS |
| Temazepam | TEMAZEPAM | Amneal Pharmaceuticals of New York LLC | 6248295e-8176-48f8-8e9d-bba6deacaf0d | 2024-02-16 | Boxed warning, Warnings, Adverse reactions | 198242 198241 CHB1QD2QSS |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.