NDC 80425-0358-01 - Clonazepam
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
- 80425-0358
- Requested NDC
- 80425-0358-01
- Package NDCs from labels
- 80425-0358-1, 80425-0358-2, 80425-0358-3, 80425-0358-01
- Manufacturer
- Advanced Rx 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 |
|---|---|---|---|
| Clonazepam - Advanced Rx of Tennessee, LLC | Advanced Rx of Tennessee, LLC | 2024-12-31 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80425-0358-1 | Clonazepam | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | 2 | |
| 80425-0358-2 | Clonazepam | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | 2 | |
| 80425-0358-3 | Clonazepam | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80425-0358 | CLONAZEPAM TABLET [ADVANCED RX OF TENNESSEE, LLC] | 2 | Current NDC, 3 package rows | 20250101_04db8e8c-38f9-0c4a-e063-6394a90a93f0.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80425-0358-1 | EA - Each | 80425-0358 | 18c1b162-1578-45af-bca9-e2348a4f344c | 1 | 2023-10-16 |
| 80425-0358-2 | EA - Each | 80425-0358 | 0110193a-0a55-45ee-a8e0-df324fe46d30 | 1 | 2023-10-16 |
| 80425-0358-3 | EA - Each | 80425-0358 | eb8cb3cc-4a39-4ce7-adea-7546438aaf61 | 1 | 2023-10-16 |
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 |
|---|---|---|---|---|---|---|
| Clonazepam | CLONAZEPAM | Solco Healthcare LLC | 4acbb7a9-4db5-4497-b8db-9f358b3f6fb4 | 2025-08-13 | Boxed warning, Warnings, Adverse reactions | 197528 197529 197527 5PE9FDE8GB |
| CLONAZEPAM | CLONAZEPAM | Alembic Pharmaceuticals Inc. | ecb28fcb-f0d1-4558-b460-ecabd0f6009e | 2025-07-31 | Boxed warning, Warnings, Adverse reactions | 5PE9FDE8GB |
| Clonazepam | CLONAZEPAM | Bryant Ranch Prepack | dec8b5b2-2490-4880-a8d1-707b57954297 | 2025-06-20 | Boxed warning, Warnings, Adverse reactions | 197529 5PE9FDE8GB |
| Clonazepam | CLONAZEPAM | A-S Medication Solutions | 28675dd6-b952-4e71-b0a3-b701ad6b6344 | 2025-06-09 | Boxed warning, Warnings, Adverse reactions | ANDA077147 197528 197529 197527 5PE9FDE8GB |
| Clonazepam | CLONAZEPAM | St Marys Medical Park Pharmacy | 31a7ed52-48a6-1c87-e054-00144ff88e88 | 2025-05-22 | Warnings, Adverse reactions | ANDA077147 197528 5PE9FDE8GB |
| Clonazepam | CLONAZEPAM | American Health Packaging | c13297e2-ae3e-4198-b7c8-55fd672436aa | 2025-03-21 | Boxed warning, Warnings, Adverse reactions | 197528 197527 5PE9FDE8GB |
| YVTYVT MICRODERMABRASION FACIAL SCRUB | YVTYVT MICRODERMABRASION FACIAL SCRUB | Beijing JUNGE Technology Co., Ltd. | 2f30fc45-42e2-c766-e063-6394a90a8d68 | 2025-02-28 | Warnings | OP1R32D61U |
| Clonazepam | CLONAZEPAM | Coupler LLC | 2e970dc2-cd78-bcdf-e063-6294a90ad3e0 | 2025-02-20 | Boxed warning, Warnings, Adverse reactions | 197527 5PE9FDE8GB |
| Clonazepam | CLONAZEPAM | Coupler LLC | 2cdb55a7-54e4-17b6-e063-6294a90ac827 | 2025-01-29 | Boxed warning, Warnings, Adverse reactions | 197529 5PE9FDE8GB |
| Clonazepam | CLONAZEPAM | Direct_Rx | fc75869c-cd6b-44a3-e053-6294a90a699e | 2025-01-22 | Boxed warning, Warnings, Adverse reactions | 197528 5PE9FDE8GB |
| CLONAZEPAM | CLONAZEPAM | DIRECT RX | a821f647-be5f-274c-e053-2a95a90a23ce | 2025-01-17 | Warnings, Adverse reactions | 197527 5PE9FDE8GB |
| Clonazepam | CLONAZEPAM | Advanced Rx of Tennessee, LLC | 04db8e8c-38f9-0c4a-e063-6394a90a93f0 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | ANDA077147 80425-0358-1 80425-0358-2 80425-0358-3 80425-0358 80425035801 197527 2a99a670-af28-299d-e063-6294a90a05d2 04db8e8c-38f9-0c4a-e063-6394a90a93f0 5PE9FDE8GB |
| Clonazepam | CLONAZEPAM | Advanced Rx Pharmacy of Tennessee, LLC | b9309a1a-a794-2f62-e053-2a95a90a7c34 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | ANDA077147 197527 5PE9FDE8GB |
| Clonazepam | CLONAZEPAM | Advanced Rx Pharmacy of Tennessee, LLC | be383e56-d71f-7699-e053-2995a90a50c1 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | ANDA077147 197528 5PE9FDE8GB |
| Clonazepam | CLONAZEPAM | Aphena Pharma Solutions - Tennessee, LLC | 263f99eb-9744-5601-e063-6394a90a47b1 | 2024-11-14 | Warnings, Adverse reactions | 197527 5PE9FDE8GB |
| Clonazepam | CLONAZEPAM | Aphena Pharma Solutions - Tennessee, LLC | 8891c5aa-f42a-4206-92b9-f0ed0631dfcb | 2024-10-23 | Boxed warning, Warnings, Adverse reactions | 197527 5PE9FDE8GB |
| Clonazepam | CLONAZEPAM | Aphena Pharma Solutions - Tennessee, LLC | 214e760b-c909-bd93-e063-6294a90ae74a | 2024-10-22 | Boxed warning, Warnings, Adverse reactions | 197527 5PE9FDE8GB |
| Clonazepam | CLONAZEPAM | NuCare Pharmaceuticals,Inc. | 555061d4-276a-4716-e054-00144ff88e88 | 2024-10-16 | Warnings, Adverse reactions | ANDA077147 197527 5PE9FDE8GB |
| Clonazepam | CLONAZEPAM | Aphena Pharma Solutions - Tennessee, LLC | 66bf60fa-61ac-47a7-a081-36077af9007e | 2024-10-14 | Warnings, Adverse reactions | 197527 5PE9FDE8GB |
| Clonazepam | CLONAZEPAM | Aphena Pharma Solutions - Tennessee, LLC | 7b0d716c-8f51-47a7-8bf2-07c6f9732a05 | 2024-09-29 | Warnings, Adverse reactions | ANDA077147 197527 5PE9FDE8GB |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.