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 | NuCare Pharmaceuticals,Inc. | 8fa33078-c379-41f5-e053-2995a90acced | 2024-10-09 | Boxed warning, Warnings, Adverse reactions | ANDA203572 197901 O26FZP769L |
| Lorazepam | LORAZEPAM | NuCare Pharmaceuticals, Inc. | 4a66b854-4dc1-3746-e054-00144ff8d46c | 2024-10-08 | Warnings, Adverse reactions | 197902 O26FZP769L |
| Lorazepam | LORAZEPAM | Bryant Ranch Prepack | 853c762d-0772-4f02-99ca-0bc2911f09f0 | 2024-08-26 | Boxed warning, Warnings, Adverse reactions | ANDA203572 197900 O26FZP769L |
| Lorazepam | LORAZEPAM | NuCare Pharmaceuticals, Inc. | 4ab77192-8fe9-2965-e054-00144ff88e88 | 2024-07-19 | Warnings, Adverse reactions | 197900 O26FZP769L |
| Lorazepam | LORAZEPAM | NuCare Pharmaceuticals,Inc. | a4fe8df0-3ce8-b8b8-e053-2995a90a28f4 | 2024-07-17 | Boxed warning, Warnings, Adverse reactions | ANDA203572 197901 O26FZP769L |
| Lorazepam | LORAZEPAM | NuCare Pharmaceuticals, Inc. | 50379c41-2676-590c-e054-00144ff8d46c | 2024-07-08 | Warnings, Adverse reactions | 197901 O26FZP769L |
| Lorazepam | LORAZEPAM | Aphena Pharma Solutions - Tennessee, LLC | 1bcf608a-11c1-ec7d-e063-6394a90ab710 | 2024-06-26 | Boxed warning, Warnings, Adverse reactions | 197902 O26FZP769L |
| Lorazepam | LORAZEPAM | NuCare Pharmaceuticals,Inc. | 8aace309-f3ef-6aef-e053-2995a90aa197 | 2024-06-19 | Boxed warning, Warnings, Adverse reactions | ANDA203572 197900 O26FZP769L |
| Lorazepam | LORAZEPAM | NuCare Pharmaceuticals,Inc. | 933b5ef3-ec29-1a96-e053-2995a90a2d33 | 2024-06-19 | Boxed warning, Warnings, Adverse reactions | ANDA203572 197900 O26FZP769L |
| Lorazepam | LORAZEPAM | Bryant Ranch Prepack | aac672f9-0ba7-4852-b8a7-caac9e4b1e77 | 2024-05-15 | Boxed warning, Warnings, Adverse reactions | 197900 O26FZP769L |
| Lorazepam | LORAZEPAM | Proficient Rx LP | e9052b38-3c9f-4c84-9a0d-98bd99b9ddfd | 2024-05-01 | Boxed warning, Warnings, Adverse reactions | 197900 O26FZP769L |
| Lorazepam | LORAZEPAM | Aphena Pharma Solutions - Tennessee, LLC | e563594e-212c-4f31-92ea-294aeab45df3 | 2024-04-12 | Boxed warning, Warnings, Adverse reactions | 197900 O26FZP769L |
| Lorazepam | LORAZEPAM | Hikma Pharmaceuticals USA Inc. | 4084fa74-9fd2-45ef-9d56-27bfa31d4e46 | 2024-04-10 | Boxed warning, Warnings, Adverse reactions | O26FZP769L |
| Lorazepam | LORAZEPAM | Hikma Pharmaceuticals USA Inc. | e9b54e42-04cf-4c62-90e1-36f7b31a4e81 | 2024-04-09 | Boxed warning, Warnings, Adverse reactions | O26FZP769L |
| Lorazepam | LORAZEPAM | Bryant Ranch Prepack | ba34ddd2-9a47-48bf-8e55-f05e9085e5a8 | 2024-04-03 | Boxed warning, Warnings, Adverse reactions | 197901 O26FZP769L |
| Lorazepam | LORAZEPAM | Bryant Ranch Prepack | 8e3d44fb-24b7-4552-9e95-de3bf871a88b | 2024-04-03 | Boxed warning, Warnings, Adverse reactions | 197902 O26FZP769L |
| Lorazepam | LORAZEPAM | International Medication Systems, Limited | 7dda070d-7809-46c4-8592-eb4e4c509707 | 2024-03-04 | Boxed warning, Warnings, Adverse reactions | O26FZP769L |
| Lorazepam | LORAZEPAM | Aphena Pharma Solutions - Tennessee, LLC | 82f79757-69f0-4a37-93a6-55b66ae86ad7 | 2024-02-06 | Boxed warning, Warnings, Adverse reactions | 197902 O26FZP769L |
| LORAZEPAM | LORAZEPAM | A-S Medication Solutions | 8602cef8-167e-4a8c-b10f-fc3295a3abcc | 2024-01-21 | Boxed warning, Warnings, Adverse reactions | ANDA203572 197901 O26FZP769L |
| Lorazepam | LORAZEPAM | Aphena Pharma Solutions - Tennessee, LLC | 973eff80-b2cd-42ca-8e88-e0151e691e59 | 2024-01-19 | Boxed warning, Warnings, Adverse reactions | 197901 O26FZP769L |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.