NDC 80425-0187-03 - 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
- 80425-0187-03
- Package NDCs from labels
- 80425-0187-1, 80425-0187-2, 80425-0187-3, 80425-0187-03
- 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 | Aurobindo Pharma Limited | 7ce17c02-7f1f-4d52-8b6f-52e385e12239 | 2026-09-04 | Warnings, Adverse reactions | 313412 313413 B53E3NMY5C |
| tizanidine | TIZANIDINE | REMEDYREPACK INC. | 63b7eba3-6dea-4d89-bc42-7e965ae9795d | 2026-08-28 | Warnings, Adverse reactions | 313413 B53E3NMY5C |
| Tizanidine | TIZANIDINE | Redpharm Drug | 59d83e3a-5e44-d8d0-e063-6294a90aa65a | 2026-08-25 | Warnings, Adverse reactions | 313412 B53E3NMY5C |
| Tizanidine | TIZANIDINE | REMEDYREPACK INC. | 9bcc7f09-d2b5-4602-aaf3-5410b55ce275 | 2026-08-14 | Warnings, Adverse reactions | 313413 B53E3NMY5C |
| Tizanidine | TIZANIDINE | Aphena Pharma Solutions - Tennessee, LLC | 25db7cc0-604c-3d6b-e063-6394a90a337f | 2026-08-04 | Warnings, Adverse reactions | 313413 B53E3NMY5C |
| Tizanidine | TIZANIDINE | NuCare Pharmaceuticals,Inc. | 6dd9946f-b2a4-1732-e053-2a91aa0a648f | 2026-07-24 | Warnings, Adverse reactions | ANDA091283 313413 B53E3NMY5C |
| tizanidine | TIZANIDINE | Preferred Pharmaceuticals Inc. | 8d0b2b22-e1df-4ad5-92e6-f9a369108e4b | 2026-07-16 | Warnings, Adverse reactions | 313413 B53E3NMY5C |
| Tizanidne hydrochloride | TIZANIDNE HYDROCHLORIDE | Bryant Ranch Prepack | 649f1f76-da33-4bdf-a38d-5ae3a9cb7987 | 2026-07-09 | Warnings, Adverse reactions | B53E3NMY5C |
| Tizanidine | TIZANIDINE | REMEDYREPACK INC. | b14bd166-9f53-4f2e-be05-c447af04ef69 | 2026-07-08 | Warnings, Adverse reactions | ANDA091283 313413 B53E3NMY5C |
| Tizanidine | TIZANIDINE | HAWAII REPACK, INC. | 45de30ce-959f-4e2e-a974-6f90568139c9 | 2026-06-25 | Warnings, Adverse reactions | 313412 313413 B53E3NMY5C |
| Tizanidine | TIZANIDINE | REMEDYREPACK INC. | 59084f59-9a9b-49f0-a9f4-27f3eab9a228 | 2026-06-23 | Warnings, Adverse reactions | 313413 B53E3NMY5C |
| Tizanidine | TIZANIDINE | Redpharm Drug | 54ade0c7-4bf0-54d4-e063-6294a90a8b17 | 2026-06-20 | Warnings, Adverse reactions | 313413 B53E3NMY5C |
| Tizanidine | TIZANIDINE | St. Mary's Medical Park Pharmacy | c6b4486f-e847-64ee-e053-2995a90a855a | 2026-06-19 | Warnings, Adverse reactions | 313413 B53E3NMY5C |
| Tizanidine | TIZANIDINE | Direct_Rx | 5460dbf8-b30d-db94-e063-6394a90a5553 | 2026-06-16 | Warnings, Adverse reactions | B53E3NMY5C |
| Tizanidine | TIZANIDINE | St. Mary's Medical Park Pharmacy | cfd52c0c-a7c2-e23d-e053-2a95a90abbd1 | 2026-06-15 | Warnings, Adverse reactions | 313412 B53E3NMY5C |
| tizanidine | TIZANIDINE | Major Pharmaceuticals | d24e0cda-a22f-404f-b861-f85090cef099 | 2026-06-15 | Warnings, Adverse reactions | 313413 B53E3NMY5C |
| Tizanidne hydrochloride | TIZANIDNE HYDROCHLORIDE | Bryant Ranch Prepack | 70b1a815-8549-4602-af35-fdbedf5fad51 | 2026-05-21 | Warnings, Adverse reactions | B53E3NMY5C |
| Tizanidne hydrochloride | TIZANIDNE HYDROCHLORIDE | Bryant Ranch Prepack | 4fd5b1b8-ec86-42c2-9065-aee581f1bdd6 | 2026-05-21 | Warnings, Adverse reactions | B53E3NMY5C |
| Tizanidne hydrochloride | TIZANIDNE HYDROCHLORIDE | Bryant Ranch Prepack | 226b506f-6f85-48e8-b8e5-86442d74d951 | 2026-05-21 | Warnings, Adverse reactions | B53E3NMY5C |
| Tizanidine | TIZANIDINE | Medcore LLC | 14bcfbac-8f6a-42af-b3a4-ba10d99f2468 | 2026-04-14 | Warnings, Adverse reactions | 313412 313413 B53E3NMY5C |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.