NDC 80425-0144-01 - Tizanidine 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
- 80425-0144
- Requested NDC
- 80425-0144-01
- Package NDCs from labels
- 80425-0144-3, 80425-0144-2, 80425-0144-1, 80425-0144-4, 80425-0144-01
- Manufacturer
- Advanced Rx Pharmacy of Tennessee, LLC
- Effective date
- 2025-11-17
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Tizanidine HCL - Advanced Rx Pharmacy of Tennessee, LLC | Advanced Rx Pharmacy of Tennessee, LLC | 2025-11-17 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80425-0144-1 | Tizanidine HCL | 30 in 1 BOTTLE | CAPSULE | 30 | 9 | |
| 80425-0144-2 | Tizanidine HCL | 60 in 1 BOTTLE | CAPSULE | 60 | 9 | |
| 80425-0144-3 | Tizanidine HCL | 90 in 1 BOTTLE | CAPSULE | 90 | 9 | |
| 80425-0144-4 | Tizanidine HCL | 120 in 1 BOTTLE | CAPSULE | 120 | 9 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80425-0144 | TIZANIDINE HCL CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 8 | Current NDC, Legacy NDC, 4 package rows | 20250101_c46c7aa3-69db-82dc-e053-2995a90ac251.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80425-0144-1 | EA - Each | 80425-0144 | b99d8b6e-963c-4879-8b61-3267b63e9b19 | 1 | 2023-06-06 |
| 80425-0144-2 | EA - Each | 80425-0144 | 2c88d83a-8c4b-4926-80b5-8419ee8e0ed4 | 1 | 2023-06-06 |
| 80425-0144-3 | EA - Each | 80425-0144 | 4ef89d59-832a-4d98-ae18-e74972a19a02 | 1 | 2023-06-06 |
| 80425-0144-4 | EA - Each | 80425-0144 | 35e993ff-b889-457e-a09e-a02fbef0a6ca | 1 | 2025-12-16 |
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 |
|---|---|---|---|---|---|---|
| Tizanidne hydrochloride | TIZANIDNE HYDROCHLORIDE | Bryant Ranch Prepack | a4233306-2954-496f-9686-22c48041710d | 2024-08-07 | Warnings, Adverse reactions | ANDA212196 485484 B53E3NMY5C |
| tizanidine | TIZANIDINE | NCS HealthCare of KY, LLC dba Vangard Labs | c8278b4e-cca2-4880-8924-c8202ce084d6 | 2024-08-05 | Warnings, Adverse reactions | B53E3NMY5C |
| Tizanidne hydrochloride | TIZANIDNE HYDROCHLORIDE | Bryant Ranch Prepack | 30df9966-5076-449f-867b-28cb9b835693 | 2024-05-31 | Warnings, Adverse reactions | ANDA212196 485486 B53E3NMY5C |
| TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | Bryant Ranch Prepack | ff7a82ea-c03c-44f6-9b15-468cb8d15a9c | 2024-04-05 | Warnings, Adverse reactions | 485484 B53E3NMY5C |
| Tizanidine | TIZANIDINE | Proficient Rx LP | e13b111a-25b7-4fdd-a102-30f2996722f3 | 2024-02-01 | Warnings, Adverse reactions | B53E3NMY5C |
| Tizanidine | TIZANIDINE | Bryant Ranch Prepack | 5f8a5b21-4adb-4f2c-91ae-bc33c3810752 | 2024-01-11 | Warnings, Adverse reactions | B53E3NMY5C |
| Tizanidine | TIZANIDINE | Bryant Ranch Prepack | 492c99bd-2cd0-43be-bd70-800b739b7e83 | 2024-01-08 | Warnings, Adverse reactions | B53E3NMY5C |
| Tizanidine | TIZANIDINE | Bryant Ranch Prepack | dd3bf952-50b1-4d50-9073-57fd6888053b | 2023-12-07 | Warnings, Adverse reactions | B53E3NMY5C |
| Tizanidine | TIZANIDINE | Bryant Ranch Prepack | 81501cb1-0a76-4bd0-8eee-dbd1e4a0b69f | 2023-12-07 | Warnings, Adverse reactions | B53E3NMY5C |
| Tizanidine | TIZANIDINE | Bryant Ranch Prepack | 51da17a0-63d2-44fb-a79d-a3bee862e028 | 2023-11-29 | Warnings, Adverse reactions | B53E3NMY5C |
| Tizanidine | TIZANIDINE | Bryant Ranch Prepack | 03fa03a6-fd05-4f17-872a-3c123330935d | 2023-11-09 | Warnings, Adverse reactions | B53E3NMY5C |
| Tizanidine | TIZANIDINE | A-S Medication Solutions | 67b2af93-92c9-4c33-8fa0-548bfcc9c538 | 2023-10-18 | Warnings, Adverse reactions | B53E3NMY5C |
| Tizanidine | TIZANIDINE | A-S Medication Solutions | 247ae1f4-6ec8-4e34-aae4-13495d8f64e5 | 2023-10-18 | Warnings, Adverse reactions | B53E3NMY5C |
| Tizanidine | TIZANIDINE | Bryant Ranch Prepack | 5a5b6614-038f-4e5b-9543-0497872c7882 | 2023-09-13 | Warnings, Adverse reactions | B53E3NMY5C |
| Tizanidine | TIZANIDINE | Ascend Laboratories, LLC | 72f25135-1333-4e52-83f5-7df7d90e68bb | 2023-03-13 | Warnings, Adverse reactions | B53E3NMY5C |
| tizanidine hydrochloride | TIZANIDINE HYDROCHLORIDE | Actavis Pharma, Inc. | cb8b01b3-bcec-4762-9d67-0db018ef6b22 | 2023-03-10 | Warnings, Adverse reactions | 485485 485486 485484 B53E3NMY5C |
| Tizanidine Hydrochloride | TIZANIDINE HYDROCHLORIDE | Alembic Pharmaceuticals Limited | 29750221-497e-4747-a9b8-12a0c2236eae | 2023-01-30 | Warnings, Adverse reactions | 485485 485486 485484 B53E3NMY5C |
| Tizanidne hydrochloride | TIZANIDNE HYDROCHLORIDE | Asclemed USA, Inc. | 1ad6eaf6-bd32-4d05-bdd0-a6246e2afb9c | 2022-07-07 | Warnings, Adverse reactions | ANDA212196 485484 B53E3NMY5C |
| tizanidine | TIZANIDINE | Proficient Rx LP | cf77e63c-a62a-43fc-8705-0558925e04e8 | 2022-07-01 | Warnings, Adverse reactions | B53E3NMY5C |
| Tizanidine | TIZANIDINE | Proficient Rx LP | 5b7b4721-e6fa-4586-ac40-091ad363ee85 | 2022-04-01 | Warnings, Adverse reactions | B53E3NMY5C |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.