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 | Preferred Pharmaceuticals Inc. | 2fe0d214-9c4d-4a0c-9024-c2076c092c1a | 2026-03-31 | Boxed warning, Warnings, Adverse reactions | 197529 5PE9FDE8GB |
| Clonazepam | CLONAZEPAM | Preferred Pharmaceuticals Inc. | f803fefc-69ff-4963-950b-48c13998bc2c | 2026-03-31 | Boxed warning, Warnings, Adverse reactions | 197528 5PE9FDE8GB |
| Clonazepam | CLONAZEPAM | Preferred Pharmaceuticals Inc. | 87f362a7-cf66-4166-af51-ac2da473cf6b | 2026-03-31 | Boxed warning, Warnings, Adverse reactions | 197528 5PE9FDE8GB |
| Clonazepam | CLONAZEPAM | Preferred Pharmaceuticals Inc. | 939dee35-3987-4ce2-9985-3751ceffa20e | 2026-03-30 | Boxed warning, Warnings, Adverse reactions | 197527 5PE9FDE8GB |
| Clonazepam | CLONAZEPAM | REMEDYREPACK INC. | 00f323c0-e007-40df-ae7f-e6b3c7ba0aa8 | 2026-03-16 | Boxed warning, Warnings, Adverse reactions | ANDA077147 197527 5PE9FDE8GB |
| Clonazepam | CLONAZEPAM | Proficient Rx LP | 44f39aa8-a7bc-4e42-977c-31583e6388ae | 2026-03-01 | Boxed warning, Warnings, Adverse reactions | 197528 5PE9FDE8GB |
| Clonazepam | CLONAZEPAM | AvPAK | f2662808-01c4-330c-e053-2a95a90aa335 | 2026-02-24 | Warnings, Adverse reactions | 197528 197529 197527 5PE9FDE8GB |
| Clonazepam | CLONAZEPAM | REMEDYREPACK INC. | a4185456-68f9-47d4-9952-fcdef86989db | 2026-02-04 | Boxed warning, Warnings, Adverse reactions | ANDA077147 197528 5PE9FDE8GB |
| Clonazepam | CLONAZEPAM | REMEDYREPACK INC. | 095a80b0-09f9-4bd1-b377-5212d7c966ba | 2026-02-03 | Boxed warning, Warnings, Adverse reactions | ANDA077147 197529 5PE9FDE8GB |
| Lotrimin Daily Sweat and Odor Control | TOPICAL STARCH | Bayer HealthCare LLC. | 9ec5c80d-b550-496f-e053-2a95a90a5489 | 2026-01-16 | Warnings | O8232NY3SJ |
| Clonazepam | CLONAZEPAM | Northstar Rx LLC | 017534e6-49ff-45f3-b88f-2f34cf0cf8fd | 2026-01-02 | Boxed warning, Warnings, Adverse reactions | 197528 197529 197527 5PE9FDE8GB |
| Medicated Cornstarch Baby Powder | ACTIVE CORN STARCH | Davion, Inc. | e39032d1-c8cd-4a41-af10-126970b8ad38 | 2025-12-29 | Warnings | O8232NY3SJ |
| Klonopin | CLONAZEPAM | H2-Pharma, LLC | cfa0d79a-843c-4b88-95a1-e9511d649ca1 | 2025-12-01 | Boxed warning, Warnings, Adverse reactions | 197528 197529 197527 5PE9FDE8GB |
| Clonazepam | CLONAZEPAM | PD-Rx Pharmaceuticals, Inc. | 9ee4e019-6a99-4aac-84b0-9aae597815a7 | 2025-10-17 | Boxed warning, Warnings, Adverse reactions | ANDA077147 197528 5PE9FDE8GB |
| Clonazepam | CLONAZEPAM | PD-Rx Pharmaceuticals, Inc. | c707caa1-d6fd-4790-9a64-f749bf93ef18 | 2025-10-17 | Boxed warning, Warnings, Adverse reactions | ANDA077147 197527 5PE9FDE8GB |
| Clonazepam | CLONAZEPAM | PD-Rx Pharmaceuticals, Inc. | 1ce88d2c-70f7-427b-8787-4afd9ce6f71c | 2025-10-16 | Boxed warning, Warnings, Adverse reactions | ANDA077147 197529 5PE9FDE8GB |
| Clonazepam | CLONAZEPAM | Par Health USA, LLC | 1aef0069-80ea-483d-ac70-c8d485462c5b | 2025-10-06 | Boxed warning, Warnings, Adverse reactions | 5PE9FDE8GB |
| Clonazepam | CLONAZEPAM | PD-Rx Pharmaceuticals, Inc. | 08d0a109-3307-47b5-8ff2-c0ad83e66f08 | 2025-10-01 | Boxed warning, Warnings, Adverse reactions | 197527 5PE9FDE8GB |
| Clonazepam | CLONAZEPAM | PD-Rx Pharmaceuticals, Inc. | 9a74ea97-1c00-4d96-a06f-81c183943dc6 | 2025-10-01 | Boxed warning, Warnings, Adverse reactions | 197529 5PE9FDE8GB |
| Clonazepam | CLONAZEPAM | PD-Rx Pharmaceuticals, Inc. | ca79f244-7e6e-4612-af26-e6e5cefbd3a2 | 2025-10-01 | Boxed warning, Warnings, Adverse reactions | 197528 5PE9FDE8GB |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.