NDC 80425-0155-01 - Cyclobenzaprine HCL
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
- 80425-0155
- Requested NDC
- 80425-0155-01
- Package NDCs from labels
- 80425-0155-4, 80425-0155-1, 80425-0155-3, 80425-0155-2, 80425-0155-5, 80425-0155-01
- 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 |
|---|---|---|---|
| Cyclobenzaprine HCL - 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 |
|---|---|---|---|---|---|---|
| 80425-0155-1 | Cyclobenzaprine HCL | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 9 | |
| 80425-0155-2 | Cyclobenzaprine HCL | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | 9 | |
| 80425-0155-3 | Cyclobenzaprine HCL | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 9 | |
| 80425-0155-4 | Cyclobenzaprine HCL | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | 9 | |
| 80425-0155-5 | Cyclobenzaprine HCL | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | 9 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80425-0155 | CYCLOBENZAPRINE HCL TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 9 | Current NDC, Legacy NDC, 5 package rows | 20250101_c859f63a-09de-4eec-e053-2a95a90a312f.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80425-0155-1 | EA - Each | 80425-0155 | f4bcb5d0-e79e-475a-abc2-3f28285e7901 | 1 | 2023-03-13 |
| 80425-0155-2 | EA - Each | 80425-0155 | ff5212cb-fd0d-4c91-9128-b6d93df2f0a5 | 1 | 2023-03-13 |
| 80425-0155-3 | EA - Each | 80425-0155 | 852908d7-d274-45fc-92c2-ffaa1f1c5180 | 1 | 2023-03-13 |
| 80425-0155-4 | EA - Each | 80425-0155 | c18b3c89-d4bf-4582-8fb2-7d8d6de5e2ad | 1 | 2023-03-13 |
| 80425-0155-5 | EA - Each | 80425-0155 | 3ea3d38f-4c76-4368-bd3d-7ea8652826ad | 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 |
|---|---|---|---|---|---|---|
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 3aaa4808-7f2d-410c-9b6c-193549ec0845 | 2025-04-30 | Warnings, Adverse reactions | 828348 0VE05JYS2P |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 7829a96a-3668-4d88-90e9-0ecbedb2bd7e | 2025-04-30 | Warnings, Adverse reactions | 828348 0VE05JYS2P |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 3baeda95-d098-437a-b360-87a9c3f3fd9b | 2025-04-30 | Warnings, Adverse reactions | 828320 0VE05JYS2P |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | Redpharm Drug | 0ab1b6f8-5d73-f97a-e063-6294a90a9fbf | 2025-04-09 | Warnings, Adverse reactions | 828348 0VE05JYS2P |
| Fexmid | CYCLOBENZAPRINE HYDROCHLORIDE | Rising Pharma Holdings, Inc. | 41838966-de0b-4855-83b8-2ff6c764ed1f | 2025-04-07 | Warnings, Adverse reactions | 828299 0VE05JYS2P |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Bryant Ranch Prepack | 3f1b9c8a-8f75-4b84-af0c-739815937fd7 | 2025-04-01 | Warnings, Adverse reactions | 828320 0VE05JYS2P |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Bryant Ranch Prepack | 2169667d-4f4b-472d-929b-8a0bcbddbe9c | 2025-03-26 | Warnings, Adverse reactions | 0VE05JYS2P |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Bryant Ranch Prepack | dcef9b63-f998-4852-920d-c356623cea6a | 2025-03-21 | Warnings, Adverse reactions | 828320 0VE05JYS2P |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 30ca08c7-4ee3-2f37-e063-6294a90ae31a | 2025-03-20 | Warnings, Adverse reactions | 828348 0VE05JYS2P |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Jubilant Cadista Pharmaceuticals Inc. | 592871f6-0eb2-4624-9e10-bd8bf767c002 | 2025-02-21 | Warnings, Adverse reactions | 828299 828320 828348 0VE05JYS2P |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Rising Pharma Holdings, Inc. | 6018b6e9-938d-4fc9-86d7-1fd1d7bfcc58 | 2025-02-20 | Warnings, Adverse reactions | 828320 828348 0VE05JYS2P |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Upsher-Smith Laboratories, LLC | 14f64ceb-ea5c-4d7c-a0c1-3f6a64847290 | 2025-02-20 | Warnings, Adverse reactions | 0VE05JYS2P |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Bryant Ranch Prepack | aa29e260-fb77-415a-a505-3230d30c8945 | 2025-02-10 | Warnings, Adverse reactions | 828348 0VE05JYS2P |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | fbd38abb-02ae-1a36-e053-6294a90abe65 | 2025-02-04 | Warnings, Adverse reactions | ANDA213324 828348 0VE05JYS2P |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | Asclemed USA, Inc. | 418e3974-f7dd-4f27-bee5-3c2fb0531c4c | 2025-02-03 | Warnings, Adverse reactions | 828299 828320 828348 0VE05JYS2P |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | Bryant Ranch Prepack | 05641925-7b10-4b30-b6e8-44b416a5e77e | 2025-02-03 | Warnings, Adverse reactions | 828320 0VE05JYS2P |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | Bryant Ranch Prepack | 96207b29-033b-46a3-961f-e5125288d50f | 2025-02-03 | Warnings, Adverse reactions | 828348 0VE05JYS2P |
| Cyclobenzaprine hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Redpharm Drug, Inc. | 09d0e2fc-76a4-bb7d-e063-6394a90a4a7d | 2025-01-23 | Warnings, Adverse reactions | ANDA213324 828348 0VE05JYS2P |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Redpharm Drug | fc61c9f5-b0ec-3ff8-e053-6394a90adeb7 | 2025-01-23 | Warnings, Adverse reactions | 828348 0VE05JYS2P |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Redpharm Drug | 09d35c34-11fa-3a5d-e063-6294a90ab172 | 2025-01-23 | Warnings, Adverse reactions | 828348 0VE05JYS2P |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.