Prescription drug · ANDA
tizanidine NDC 72578-096
Tizanidine hydrochloride 2 mg/1 · Tablet · Oral · Viona Pharmaceuticals Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72578-096-06 | 72578009606 | 30 TABLET in 1 BOTTLE (72578-096-06)Marketed from Mar 4, 2021 | |
| 72578-096-10 | 72578009610 | 1000 TABLET in 1 BOTTLE (72578-096-10)Marketed from Mar 4, 2021 | |
| 72578-096-21 | 72578009621 | 150 TABLET in 1 BOTTLE (72578-096-21)Marketed from Mar 4, 2021 | |
| 72578-096-77 | 72578009677 | 10 BLISTER PACK in 1 CARTON (72578-096-77) / 10 TABLET in 1 BLISTER PACK (72578-096-30)Marketed from Mar 4, 2021 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- tizanidine
- Generic name (nonproprietary)
- tizanidine
- Active ingredients
- Tizanidine hydrochloride — 2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Viona Pharmaceuticals Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208187
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)
- Identifiers
- Product ID 72578-096_8fd84300-3ed6-42ff-b20c-608ea5dc96ebSPL ID 8fd84300-3ed6-42ff-b20c-608ea5dc96ebSPL set ID 8ac00d59-bb80-4530-afe7-90e04a2130b2RxCUI 313412, 313413UNII B53E3NMY5C
- Pharmacologic class
- Central alpha-2 Adrenergic Agonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N472578009606followed by a unit qualifier and the quantityPackage 72578-0096-06. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Tizanidine tablets are a central alpha-2-adrenergic agonist indicated for the treatment of spasticity. ( 1 ) Tizanidine tablets are indicated for the treatment of spasticity in adults.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 208187
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0436 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0453 |
| tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0454 |
| tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Viona Pharmaceuticals Inc | 72578-097 |
| tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0500 |
| tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1335 |
| tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1336 |
| tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3719 |
| tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-886 |
| tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4181 |
| tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-885 |
| tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8468 |
| tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Coupler LLC | 67046-1444 |
| tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8469 |