NDC 80425-0187-01 - Tizanidine
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
- 80425-0187
- Requested NDC
- 80425-0187-01
- Package NDCs from labels
- 80425-0187-1, 80425-0187-2, 80425-0187-3, 80425-0187-01
- Manufacturer
- Advanced Rx Pharmacy of Tennessee, LLC
- Effective date
- 2024-09-12
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Tizanidine - Advanced Rx Pharmacy of Tennessee, LLC | Advanced Rx Pharmacy of Tennessee, LLC | 2024-09-12 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80425-0187-1 | Tizanidine | 30 in 1 BOTTLE | TABLET | 30 | 5 | |
| 80425-0187-2 | Tizanidine | 60 in 1 BOTTLE | TABLET | 60 | 5 | |
| 80425-0187-3 | Tizanidine | 90 in 1 BOTTLE | TABLET | 90 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80425-0187 | TIZANIDINE TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 5 | Current NDC, Legacy NDC, 3 package rows | 20240913_d2961d1c-5de2-0a2b-e053-2995a90ad2fc.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80425-0187-1 | EA - Each | 80425-0187 | 1974c522-2406-4ece-90e7-1c4a1e6eba4c | 1 | 2023-04-07 |
| 80425-0187-2 | EA - Each | 80425-0187 | dfa9dda2-4278-4ecf-b9c2-418d29a000be | 1 | 2023-06-06 |
| 80425-0187-3 | EA - Each | 80425-0187 | a6a50647-5074-4a52-92a9-5587fef9789f | 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 |
|---|---|---|---|---|---|---|
| Tizanidine | TIZANIDINE | Asclemed USA, Inc. | 24d8b33f-d1fb-4b4a-afbe-e2e7134dce29 | 2025-07-24 | Warnings, Adverse reactions | 313412 313413 B53E3NMY5C |
| Tizanidine | TIZANIDINE | PHOENIX RX LLC | 3a7b9b9a-9bf9-0b37-e063-6294a90a1c39 | 2025-07-21 | Warnings, Adverse reactions | 313413 B53E3NMY5C |
| Tizanidine | TIZANIDINE | PD-Rx Pharmaceuticals, Inc. | 615dfd5c-125a-40e2-a6da-afacde305282 | 2025-07-17 | Warnings, Adverse reactions | ANDA091283 313412 B53E3NMY5C |
| Tizanidine | TIZANIDINE | Unichem Pharmaceuticals (USA), Inc. | a3fa9c69-4baf-44f5-bac4-a19c34b0e1cb | 2025-05-27 | Warnings, Adverse reactions | ANDA091283 29300-168 313412 313413 06c83876-99c5-4ed1-8727-1a0d93452020 a3fa9c69-4baf-44f5-bac4-a19c34b0e1cb B53E3NMY5C |
| Tizanidine | TIZANIDINE | American Health Packaging | 3670f9e3-988d-48e6-9df0-d403d699e08a | 2025-05-22 | Warnings, Adverse reactions | 313412 313413 B53E3NMY5C |
| Tizanidine | TIZANIDINE | Bryant Ranch Prepack | 73269d77-16b5-4787-9a7d-1b8688623436 | 2025-05-22 | Warnings, Adverse reactions | 313412 B53E3NMY5C |
| Zanaflex | TIZANIDINE HYDROCHLORIDE | Covis Pharma US, Inc | 043d9e51-bfa2-4add-9058-5ece332f7e99 | 2025-05-05 | Warnings, Adverse reactions | 313413 B53E3NMY5C |
| Tizanidine | TIZANIDINE | Asclemed USA, Inc. | 2f460275-565f-4737-a3df-bf80b9acc268 | 2025-05-02 | Warnings, Adverse reactions | 313412 313413 B53E3NMY5C |
| Tizanidine | TIZANIDINE | A-S Medication Solutions | 9678a98e-4aab-4d87-b5e1-37c3109e378e | 2025-04-02 | Warnings, Adverse reactions | ANDA091283 313412 B53E3NMY5C |
| tizanidine | TIZANIDINE | Advanced Rx of Tennessee, LLC | 30caf3b3-8c1b-268e-e063-6294a90a3c8a | 2025-03-20 | Warnings, Adverse reactions | 313412 B53E3NMY5C |
| Tizanidine | TIZANIDINE | Bryant Ranch Prepack | f87e30ce-a60a-41e3-b5d6-7e2966143961 | 2025-02-19 | Warnings, Adverse reactions | ANDA091283 313412 313413 B53E3NMY5C |
| tizanidine | TIZANIDINE | Coupler LLC | 2d9a2492-d914-f87b-e063-6394a90a38c6 | 2025-02-07 | Warnings, Adverse reactions | 313413 B53E3NMY5C |
| Tizanidine | TIZANIDINE | NuCare Pharmaceuticals,Inc. | fe2f5064-0b7c-d03d-e053-6294a90a9604 | 2025-02-04 | Warnings, Adverse reactions | 313412 B53E3NMY5C |
| Tizanidine | TIZANIDINE | Direct_rx | 2a91884a-39c3-f7ac-e063-6394a90ade14 | 2025-02-03 | Warnings, Adverse reactions | 313413 B53E3NMY5C |
| Tizanidine | TIZANIDINE | Proficient Rx LP | c2353d09-3cb4-486e-8ae7-29339c1ba76b | 2025-02-01 | Warnings, Adverse reactions | 313413 B53E3NMY5C |
| tizanidine | TIZANIDINE | Aphena Pharma Solutions - Tennessee, LLC | ef7673f4-e0c1-4d79-af36-2f2ed2cc28f7 | 2025-01-29 | Warnings, Adverse reactions | 313413 B53E3NMY5C |
| Tizanidine hydrochloride | TIZANIDINE HYDROCHLORIDE | Modavar Pharmaceuticals LLC | f8288ccd-6c66-415e-a06b-758971afe9a0 | 2025-01-29 | Warnings, Adverse reactions | B53E3NMY5C |
| Tizanidine | TIZANIDINE | NorthStar Rx LLC | eed74219-9d4a-fecd-1bb9-ad6c01ad3e9d | 2025-01-27 | Warnings, Adverse reactions | 313412 313413 B53E3NMY5C |
| tizanidine hydrochloride | TIZANIDINE HYDROCHLORIDE | Bryant Ranch Prepack | 58c10b87-004e-4d2d-b5c1-b353c2cd071f | 2025-01-24 | Warnings, Adverse reactions | B53E3NMY5C |
| Tizanidine Hydrochloride | TIZANIDINE HYDROCHLORIDE | Aurobindo Pharma Limited | 19cf46b5-d8dc-44cb-83d6-bacea0870dbe | 2025-01-17 | Warnings, Adverse reactions | B53E3NMY5C |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.