NDC 80425-0465-01 - LORAZEPAM
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
- 80425-0465
- Requested NDC
- 80425-0465-01
- Package NDCs from labels
- 80425-0465-2, 80425-0465-1, 80425-0465-3, 80425-0465-01
- Manufacturer
- Advanced Rx of Tennessee, LLC
- Effective date
- 2024-12-28
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| LORAZEPAM - Advanced Rx of Tennessee, LLC | Advanced Rx of Tennessee, LLC | 2024-12-28 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80425-0465-1 | LORAZEPAM | 30 in 1 BOTTLE | TABLET | 30 | 1 | |
| 80425-0465-2 | LORAZEPAM | 60 in 1 BOTTLE | TABLET | 60 | 1 | |
| 80425-0465-3 | LORAZEPAM | 90 in 1 BOTTLE | TABLET | 90 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80425-0465 | LORAZEPAM TABLET [ADVANCED RX OF TENNESSEE, LLC] | 1 | Current NDC, 3 package rows | 20241229_2a57e549-390b-5482-e063-6394a90aeb3b.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80425-0465-1 | EA - Each | 80425-0465 | c9a5c15d-634e-4151-9f9d-ac45e6e2ff55 | 1 | 2025-02-10 |
| 80425-0465-2 | EA - Each | 80425-0465 | f1a7c740-4286-4317-b809-d7bdd589bada | 1 | 2025-02-10 |
| 80425-0465-3 | EA - Each | 80425-0465 | d0a1df18-ba50-4e23-81b5-85ef0801a801 | 1 | 2025-02-10 |
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 |
|---|---|---|---|---|---|---|
| Lorazepam | LORAZEPAM | Clinical Solutions Wholesale, LLC | fdc11b95-2233-42b4-b5f3-9390b5e9e1b2 | 2024-01-09 | Boxed warning, Warnings, Adverse reactions | 197901 197900 197902 O26FZP769L |
| Lorazepam | LORAZEPAM | Aphena Pharma Solutions - Tennessee, LLC | 0ce02d7d-d855-c73f-e063-6294a90abe93 | 2023-12-19 | Boxed warning, Warnings, Adverse reactions | 197900 O26FZP769L |
| Lorazepam | LORAZEPAM | Leading Pharma, LLC | 5ca13415-4b77-4131-a9d2-6db26bc49167 | 2023-12-10 | Boxed warning, Warnings, Adverse reactions | 197901 197900 197902 O26FZP769L |
| Lorazepam | LORAZEPAM | Asclemed USA, Inc. | 91da80c8-3162-43f0-b53e-897070b26a54 | 2023-11-29 | Boxed warning, Warnings, Adverse reactions | 197900 O26FZP769L |
| LORAZEPAM | LORAZEPAM | Aphena Pharma Solutions - Tennessee, LLC | 247110f2-5468-4593-8d86-41f8c869e03d | 2023-10-17 | Boxed warning, Warnings, Adverse reactions | ANDA203572 197901 O26FZP769L |
| Lorazepam | LORAZEPAM | Chartwell RX, LLC | e075c78d-f0c6-4380-b769-bb8833d23ba5 | 2023-09-01 | Boxed warning, Warnings, Adverse reactions | O26FZP769L |
| LORAZEPAM | LORAZEPAM | A-S Medication Solutions | 823b1d71-a510-4d34-8015-60b55af23d78 | 2023-08-24 | Boxed warning, Warnings, Adverse reactions | ANDA203572 197901 O26FZP769L |
| Lorazepam | LORAZEPAM | Amneal Pharmaceuticals LLC | bf265c2e-ab2f-42e5-96cf-3998eb5a644d | 2023-07-28 | Boxed warning, Warnings, Adverse reactions | O26FZP769L |
| Lorazepam | LORAZEPAM | SUN PHARMACEUTICAL INDUSTRIES INC | 0c1caa9c-9ef1-459c-86c3-adb939130a9f | 2023-06-30 | Boxed warning, Warnings, Adverse reactions | 197901 197900 197902 O26FZP769L |
| Lorazepam | LORAZEPAM | Teva Pharmaceuticals USA, Inc. | 1bf22e97-9425-484d-bac6-519c6bae6a37 | 2023-06-01 | Boxed warning, Warnings, Adverse reactions | 197901 197900 197902 O26FZP769L |
| Lorazepam | LORAZEPAM | Proficient Rx LP | a407d3fe-ff0f-45b0-8a1e-c7a2a11c5569 | 2023-03-01 | Boxed warning, Warnings, Adverse reactions | 197900 O26FZP769L |
| Lorazepam | LORAZEPAM | Aphena Pharma Solutions - Tennessee, LLC | 8df3eed3-c936-4772-ab08-574c54dd8bf5 | 2023-01-04 | Boxed warning, Warnings, Adverse reactions | 197901 O26FZP769L |
| Lorazepam | LORAZEPAM | Pharmaceutical Associates, Inc. | 711b60a3-028d-41d4-aa17-8f976e6df23e | 2022-08-11 | Boxed warning, Warnings, Adverse reactions | O26FZP769L |
| Lorazepam | LORAZEPAM | Proficient Rx LP | 73bf2b31-5c7e-4b3a-9e97-8304931510b0 | 2022-06-01 | Boxed warning, Warnings, Adverse reactions | 197901 O26FZP769L |
| Lorazepam | LORAZEPAM | Proficient Rx LP | 5b78f7af-0ad8-4fa1-a8c0-9308fe8d9b3a | 2022-05-01 | Boxed warning, Warnings, Adverse reactions | ANDA203572 197900 O26FZP769L |
| Lorazepam | LORAZEPAM | Hikma Pharmaceuticals USA Inc. | b79b38ee-c29d-4099-964f-000031f47f5a | 2022-04-26 | Boxed warning, Warnings, Adverse reactions | O26FZP769L |
| Lorazepam | LORAZEPAM | Aphena Pharma Solutions - Tennessee, LLC | 1c956cc1-9217-46e0-80a3-7c811163d3f1 | 2021-09-30 | Boxed warning, Warnings, Adverse reactions | ANDA203572 197902 O26FZP769L |
| Lorazepam | LORAZEPAM | Civica, Inc. | 5140798d-8571-41fb-84a4-e182aac3f64c | 2021-04-27 | Boxed warning, Warnings, Adverse reactions | O26FZP769L |
| Lorazepam | LORAZEPAM | Hikma Pharmaceuticals USA Inc. | 5ff82103-cc57-4af9-9362-82a7c686271d | 2021-03-31 | Boxed warning, Warnings, Adverse reactions | O26FZP769L |
| Lorazepam | LORAZEPAM | Aphena Pharma Solutions - Tennessee, LLC | e83ae439-3fa5-453f-9073-4bf8c797df47 | 2019-03-26 | Warnings, Adverse reactions | 197900 O26FZP769L |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.