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 | Proficient Rx LP | 34ff8a08-0177-451f-9dbc-e21582346196 | 2024-01-01 | Warnings, Adverse reactions | 828320 0VE05JYS2P |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | Amneal Pharmaceuticals of New York LLC | 31bb92f6-ec8c-4636-8b07-8814417fe78e | 2023-12-31 | Warnings, Adverse reactions | 828320 828348 0VE05JYS2P |
| Cyclobenzaprine hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Bryant Ranch Prepack | 4a2d3cae-5c64-4986-9707-cc213b70b7ad | 2023-10-19 | Warnings, Adverse reactions | ANDA213324 828348 0VE05JYS2P |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | Bryant Ranch Prepack | 85128989-bfa3-4b82-94c1-f90b14ccd2f9 | 2023-10-18 | Warnings, Adverse reactions | 828320 828348 0VE05JYS2P |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Asclemed USA, Inc. | 74af1727-e84f-4dad-82be-045e7d23beaf | 2023-09-06 | Warnings, Adverse reactions | 828348 0VE05JYS2P |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | Proficient Rx LP | 88bdee56-d6d9-4f14-be77-1e6898ba36f5 | 2023-09-01 | Warnings, Adverse reactions | 828348 0VE05JYS2P |
| Cyclobenzaprine hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Bryant Ranch Prepack | 6ebaccfc-f57c-4547-ade0-6a6e204f5ea0 | 2023-03-27 | Warnings, Adverse reactions | ANDA213324 828320 0VE05JYS2P |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Asclemed USA, Inc. | 68db3c3b-8da1-4852-90b0-3172f842aa02 | 2023-03-02 | Warnings, Adverse reactions | 828348 0VE05JYS2P |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | A-S Medication Solutions | b524d150-0a83-42d1-a884-b930e49760cd | 2023-02-06 | Warnings, Adverse reactions | 828348 0VE05JYS2P |
| Cyclobenzaprine hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Unichem Pharmaceuticals (USA), Inc. | 1adcdd8a-30f9-4a7b-853c-948a5589acab | 2023-01-03 | Warnings, Adverse reactions | ANDA213324 29300-413 828299 828320 828348 cc113cd6-8904-4485-b1b2-15dd5ff7468b 1adcdd8a-30f9-4a7b-853c-948a5589acab 0VE05JYS2P |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | Asclemed USA, Inc. | 2a6b2ad9-307a-4976-98b7-1b96e0408da7 | 2022-09-14 | Warnings, Adverse reactions | 828299 0VE05JYS2P |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Asclemed USA, Inc. | f8dec4e2-3151-4a79-b194-a11a57ada0b6 | 2022-09-03 | Warnings, Adverse reactions | 828299 828320 828348 0VE05JYS2P |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Solco Healthcare U.S., LLC | f558863b-ea3f-4e4b-85e9-edb2573e7151 | 2022-08-22 | Warnings, Adverse reactions | 828320 828348 0VE05JYS2P |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | Asclemed USA, Inc. | 751f0d33-ceff-40b0-9329-9125f176e06a | 2022-07-29 | Warnings, Adverse reactions | 828320 0VE05JYS2P |
| Cyclobenzaprine hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Asclemed USA, Inc. | 59945ea1-8136-4014-acd9-cdfe6e11e8da | 2022-07-19 | Warnings, Adverse reactions | ANDA213324 828299 0VE05JYS2P |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Proficient Rx LP | e3998083-e3db-4052-9b5b-19d7aaa4e658 | 2022-07-01 | Warnings, Adverse reactions | 828320 0VE05JYS2P |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Proficient Rx LP | d8112916-28ae-452c-8ec8-a4972e5f549b | 2022-05-02 | Warnings, Adverse reactions | 0VE05JYS2P |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Proficient Rx LP | ffd82a69-a64c-4399-8f5d-bddc70cdc3cf | 2022-05-01 | Warnings, Adverse reactions | 0VE05JYS2P |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE | Proficient Rx LP | ae6de8d8-33c2-40bd-9dd3-782c879a9d8f | 2022-04-01 | Warnings, Adverse reactions | 828348 0VE05JYS2P |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | Alembic Pharmaceuticals Inc. | 3cdde96c-9fc9-4698-872a-25c05318ecb5 | 2021-11-19 | Warnings, Adverse reactions | 828299 828320 828348 0VE05JYS2P |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.