NDC 80425-0016-01 - 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
- 80425-0016
- Requested NDC
- 80425-0016-01
- Package NDCs from labels
- 80425-0016-4, 80425-0016-2, 80425-0016-1, 80425-0016-3, 80425-0016-01
- 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 |
|---|---|---|---|
| Cyclobenzaprine HCL - 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 |
|---|---|---|---|---|---|---|
| 80425-0016-1 | Cyclobenzaprine HCL | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | 9 | |
| 80425-0016-2 | Cyclobenzaprine HCL | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 9 | |
| 80425-0016-3 | Cyclobenzaprine HCL | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 9 | |
| 80425-0016-4 | Cyclobenzaprine HCL | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | 9 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80425-0016 | CYCLOBENZAPRINE HCL TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC] | 9 | Current NDC, Legacy NDC, 4 package rows | 20250101_afca1267-4d8f-7453-e053-2995a90a865c.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80425-0016-1 | EA - Each | 80425-0016 | 553b5f4f-98c3-412b-becd-97fa84f94451 | 1 | 2023-03-13 |
| 80425-0016-2 | EA - Each | 80425-0016 | fe471193-8819-43eb-88db-2bc0724a7bd3 | 1 | 2023-03-13 |
| 80425-0016-3 | EA - Each | 80425-0016 | 820b6eaa-987b-4e93-815e-c755aa14355b | 1 | 2023-03-13 |
| 80425-0016-4 | EA - Each | 80425-0016 | 916a100b-1077-409a-8f91-67bd1ab8d97b | 1 | 2023-03-13 |
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 | Advanced Rx of Tennessee, LLC | 259fb05a-4f45-9c8e-e063-6294a90a4484 | 2024-10-29 | Warnings, Adverse reactions | 0VE05JYS2P |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Bryant Ranch Prepack | bfdd9460-5dfa-4588-8f4f-9d227c1717d5 | 2024-10-24 | Warnings, Adverse reactions | 0VE05JYS2P |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Amneal Pharmaceuticals LLC | 390151d4-5fcb-46e2-92e6-de184827f43d | 2024-10-24 | Warnings, Adverse reactions | 828320 828348 0VE05JYS2P |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Bryant Ranch Prepack | 0a695685-cfec-464e-840c-32e3b7a68bd3 | 2024-08-21 | Warnings, Adverse reactions | 828320 0VE05JYS2P |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Bryant Ranch Prepack | 193744c8-ff8e-4f65-aec1-1c13f471ac82 | 2024-08-21 | Warnings, Adverse reactions | 828348 0VE05JYS2P |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Bryant Ranch Prepack | 59f31ca3-1b28-4768-bb29-520f06f4a9f5 | 2024-08-20 | Warnings, Adverse reactions | 828299 0VE05JYS2P |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE | NCS HealthCare of KY, LLC dba Vangard Labs | 53688de9-2031-4d19-b422-4000285f7f47 | 2024-08-12 | Warnings, Adverse reactions | 828348 0VE05JYS2P |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 1ac77323-7526-a129-e063-6394a90a641b | 2024-07-22 | Warnings, Adverse reactions | 828348 0VE05JYS2P |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 8bdc725e-22e3-0f32-e053-2a95a90ae8a9 | 2024-06-14 | Warnings, Adverse reactions | ANDA208170 828348 0VE05JYS2P |
| Cyclobenzaprine hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | e332763b-00c6-41bf-84ae-a07d9ef79697 | 2024-06-11 | Warnings, Adverse reactions | 828320 0VE05JYS2P |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Teva Pharmaceuticals USA, Inc. | ca74d27a-f7c6-462d-a913-1cfa061bd8f3 | 2024-05-31 | Warnings, Adverse reactions | 0VE05JYS2P |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | A-S Medication Solutions | d64ca498-81c6-4e10-ba82-3a50ee47bcfc | 2024-05-29 | Warnings, Adverse reactions | ANDA208170 828348 0VE05JYS2P |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Asclemed USA, Inc. | 07e3ec53-f1f2-4231-aec6-1772a146ba88 | 2024-05-07 | Warnings, Adverse reactions | 828299 0VE05JYS2P |
| AMRIX | CYCLOBENZAPRINE HYDROCHLORIDE | Cephalon, LLC | 3902123b-1365-ac3c-0934-afff9eeeb1bd | 2024-04-30 | Warnings, Adverse reactions | 0VE05JYS2P |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 00dbe051-a392-e2c6-e063-6394a90ab7f3 | 2024-03-27 | Warnings, Adverse reactions | ANDA208170 828348 0VE05JYS2P |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 0f8ba2c0-38e7-a536-e063-6294a90ace8d | 2024-03-26 | Warnings, Adverse reactions | ANDA208170 828348 0VE05JYS2P |
| Cyclobenzaprine hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | c68d17e2-2311-8e17-e053-2995a90a565b | 2024-03-11 | Warnings, Adverse reactions | 828299 0VE05JYS2P |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Medsource Pharmaceuticals | 12645f19-fffc-8b08-e063-6394a90a5c55 | 2024-02-27 | Warnings, Adverse reactions | 828348 0VE05JYS2P |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Bryant Ranch Prepack | 90c7a982-6442-4241-a60b-b5dfab2abb71 | 2024-01-31 | Warnings, Adverse reactions | 828348 0VE05JYS2P |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Bryant Ranch Prepack | c86303a0-7c8b-415e-acac-1070b7d0d445 | 2024-01-15 | Warnings, Adverse reactions | 828348 0VE05JYS2P |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.