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 |
|---|---|---|---|---|---|---|
| tizanidine | TIZANIDINE | NuCare Pharmaceuticals, Inc. | 26cffb1f-21a0-017f-e063-6394a90afb1a | 2025-01-14 | Warnings, Adverse reactions | B53E3NMY5C |
| Tizanidine | TIZANIDINE | NuCare Pharmaceuticals,Inc. | a7470959-8943-215b-e053-2a95a90a7878 | 2025-01-10 | Warnings, Adverse reactions | B53E3NMY5C |
| TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | Ingenus Pharmaceuticals, LLC | 99cc8f5f-b947-4ddc-99b6-1e4cef09b717 | 2025-01-10 | Warnings, Adverse reactions | 485485 485486 485484 B53E3NMY5C |
| Tizanidine | TIZANIDINE | Preferred Pharmaceuticals Inc. | 6e97c1ba-8171-4707-98ee-61afed75daac | 2025-01-02 | Warnings, Adverse reactions | B53E3NMY5C |
| Tizanidine | TIZANIDINE | Advanced Rx of Tennessee, LLC | 21b7c8a8-ee07-a204-e063-6394a90a285b | 2025-01-01 | Warnings, Adverse reactions | B53E3NMY5C |
| Tizanidine HCL | TIZANIDINE HCL | Advanced Rx of Tennessee, LLC | afc96ee6-c99b-7283-e053-2a95a90ad14d | 2024-12-31 | Warnings, Adverse reactions | B53E3NMY5C |
| Tizanidine HCL | TIZANIDINE HCL | Advanced Rx of Tennessee, LLC | af73c6ab-6c1c-94d1-e053-2a95a90a4e3c | 2024-12-31 | Warnings, Adverse reactions | B53E3NMY5C |
| tizanidine | TIZANIDINE | Asclemed USA, Inc. | a9ba9023-0c3f-4c9b-ba8e-d39d23bf35d6 | 2024-12-26 | Warnings, Adverse reactions | B53E3NMY5C |
| Tizanidine hydrochloride | TIZANIDINE HYDROCHLORIDE | Cadila Pharmaceuticals Limited | f2f4e117-0318-4bbd-aaa7-fab803714f21 | 2024-12-23 | Warnings, Adverse reactions | 485485 485486 485484 B53E3NMY5C |
| Tizanidine Hydrochloride | TIZANIDINE HYDROCHLORIDE | Alembic Pharmaceuticals Inc. | ee3e9813-a738-46d1-9c05-c931aee1495c | 2024-12-17 | Warnings, Adverse reactions | 485485 485486 485484 B53E3NMY5C |
| Tizanidine Hydrochloride | TIZANIDINE HYDROCHLORIDE | Quality Care Products LLC | 87f8a776-e8ae-4aed-a221-98ca72a2bedf | 2024-12-16 | Warnings, Adverse reactions | B53E3NMY5C |
| Tizanidine | TIZANIDINE | Quality Care Products, LLC | b68a9f81-7138-48cf-b987-b8d284e8105a | 2024-12-11 | Warnings, Adverse reactions | B53E3NMY5C |
| Tizanidine | TIZANIDINE | Dr. Reddy's Laboratories Limited | a42f3479-f2c2-8214-d547-c5cae9bfed1e | 2024-12-11 | Warnings, Adverse reactions | B53E3NMY5C |
| tizanidine | TIZANIDINE | Zydus Lifesciences Limited | 89105a78-badb-469e-966e-195fa3a53f0a | 2024-12-10 | Warnings, Adverse reactions | B53E3NMY5C |
| Tizanidne hydrochloride | TIZANIDNE HYDROCHLORIDE | Bryant Ranch Prepack | 00fcd792-18a4-45d9-9c6e-0634b54b152a | 2024-12-05 | Warnings, Adverse reactions | ANDA212196 485485 B53E3NMY5C |
| tizanidine | TIZANIDINE | Advanced Rx of Tennessee, LLC | 2788942d-87fa-e514-e063-6294a90a0971 | 2024-11-22 | Warnings, Adverse reactions | B53E3NMY5C |
| Tizanidine | TIZANIDINE | Asclemed USA, Inc. | 81385ce2-1d82-4987-8e18-83c823e10b99 | 2024-10-29 | Warnings, Adverse reactions | B53E3NMY5C |
| TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 26f8f233-5dc2-0013-e063-6394a90ab0f5 | 2024-10-29 | Warnings, Adverse reactions | 485484 B53E3NMY5C |
| Tizanidine | TIZANIDINE | Advanced Rx Pharmacy of Tennessee, LLC | d2961d1c-5de2-0a2b-e053-2995a90ad2fc | 2024-09-12 | Warnings, Adverse reactions | B53E3NMY5C |
| Tizanidine | TIZANIDINE | Bryant Ranch Prepack | e13292b0-9858-4405-8787-a2392d1b6d75 | 2024-08-28 | Warnings, Adverse reactions | B53E3NMY5C |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.