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 |
|---|---|---|---|---|---|---|
| Tizanidne hydrochloride | TIZANIDNE HYDROCHLORIDE | Bryant Ranch Prepack | a4233306-2954-496f-9686-22c48041710d | 2024-08-07 | Warnings, Adverse reactions | B53E3NMY5C |
| tizanidine | TIZANIDINE | NCS HealthCare of KY, LLC dba Vangard Labs | c8278b4e-cca2-4880-8924-c8202ce084d6 | 2024-08-05 | Warnings, Adverse reactions | 313412 313413 B53E3NMY5C |
| Tizanidne hydrochloride | TIZANIDNE HYDROCHLORIDE | Bryant Ranch Prepack | 30df9966-5076-449f-867b-28cb9b835693 | 2024-05-31 | Warnings, Adverse reactions | B53E3NMY5C |
| TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | Bryant Ranch Prepack | ff7a82ea-c03c-44f6-9b15-468cb8d15a9c | 2024-04-05 | Warnings, Adverse reactions | B53E3NMY5C |
| Tizanidine | TIZANIDINE | Proficient Rx LP | e13b111a-25b7-4fdd-a102-30f2996722f3 | 2024-02-01 | Warnings, Adverse reactions | ANDA091283 313413 B53E3NMY5C |
| Tizanidine | TIZANIDINE | Bryant Ranch Prepack | 5f8a5b21-4adb-4f2c-91ae-bc33c3810752 | 2024-01-11 | Warnings, Adverse reactions | 313412 B53E3NMY5C |
| Tizanidine | TIZANIDINE | Bryant Ranch Prepack | 492c99bd-2cd0-43be-bd70-800b739b7e83 | 2024-01-08 | Warnings, Adverse reactions | 313413 B53E3NMY5C |
| Tizanidine | TIZANIDINE | Bryant Ranch Prepack | dd3bf952-50b1-4d50-9073-57fd6888053b | 2023-12-07 | Warnings, Adverse reactions | 313413 B53E3NMY5C |
| Tizanidine | TIZANIDINE | Bryant Ranch Prepack | 81501cb1-0a76-4bd0-8eee-dbd1e4a0b69f | 2023-12-07 | Warnings, Adverse reactions | 313412 B53E3NMY5C |
| Tizanidine | TIZANIDINE | Bryant Ranch Prepack | 51da17a0-63d2-44fb-a79d-a3bee862e028 | 2023-11-29 | Warnings, Adverse reactions | 313413 B53E3NMY5C |
| Tizanidine | TIZANIDINE | Bryant Ranch Prepack | 03fa03a6-fd05-4f17-872a-3c123330935d | 2023-11-09 | Warnings, Adverse reactions | 313413 B53E3NMY5C |
| Tizanidine | TIZANIDINE | A-S Medication Solutions | 67b2af93-92c9-4c33-8fa0-548bfcc9c538 | 2023-10-18 | Warnings, Adverse reactions | 313413 B53E3NMY5C |
| Tizanidine | TIZANIDINE | A-S Medication Solutions | 247ae1f4-6ec8-4e34-aae4-13495d8f64e5 | 2023-10-18 | Warnings, Adverse reactions | 313413 B53E3NMY5C |
| Tizanidine | TIZANIDINE | Bryant Ranch Prepack | 5a5b6614-038f-4e5b-9543-0497872c7882 | 2023-09-13 | Warnings, Adverse reactions | 313412 B53E3NMY5C |
| Tizanidine | TIZANIDINE | Ascend Laboratories, LLC | 72f25135-1333-4e52-83f5-7df7d90e68bb | 2023-03-13 | Warnings, Adverse reactions | 313412 313413 B53E3NMY5C |
| tizanidine hydrochloride | TIZANIDINE HYDROCHLORIDE | Actavis Pharma, Inc. | cb8b01b3-bcec-4762-9d67-0db018ef6b22 | 2023-03-10 | Warnings, Adverse reactions | B53E3NMY5C |
| Tizanidine Hydrochloride | TIZANIDINE HYDROCHLORIDE | Alembic Pharmaceuticals Limited | 29750221-497e-4747-a9b8-12a0c2236eae | 2023-01-30 | Warnings, Adverse reactions | B53E3NMY5C |
| Tizanidne hydrochloride | TIZANIDNE HYDROCHLORIDE | Asclemed USA, Inc. | 1ad6eaf6-bd32-4d05-bdd0-a6246e2afb9c | 2022-07-07 | Warnings, Adverse reactions | B53E3NMY5C |
| tizanidine | TIZANIDINE | Proficient Rx LP | cf77e63c-a62a-43fc-8705-0558925e04e8 | 2022-07-01 | Warnings, Adverse reactions | 313413 B53E3NMY5C |
| Tizanidine | TIZANIDINE | Proficient Rx LP | 5b7b4721-e6fa-4586-ac40-091ad363ee85 | 2022-04-01 | Warnings, Adverse reactions | ANDA091283 313412 B53E3NMY5C |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.