Prescription drug · ANDA
Tizanidine NDC 71610-864
Tizanidine hydrochloride 4 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-864-16 | 71610086416 | 6000 TABLET in 1 BOTTLE (71610-864-16)Marketed from Oct 29, 2024 | |
| 71610-864-30 | 71610086430 | 30 TABLET in 1 BOTTLE (71610-864-30)Marketed from Jul 2, 2025 | |
| 71610-864-53 | 71610086453 | 60 TABLET in 1 BOTTLE (71610-864-53)Marketed from Jan 24, 2025 | |
| 71610-864-60 | 71610086460 | 90 TABLET in 1 BOTTLE (71610-864-60)Marketed from Jan 24, 2025 | |
| 71610-864-75 | 71610086475 | 7500 TABLET in 1 BOTTLE (71610-864-75)Marketed from Aug 3, 2026 | |
| 71610-864-80 | 71610086480 | 180 TABLET in 1 BOTTLE (71610-864-80)Marketed from Jan 31, 2025 |
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 — 4 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076416
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)
- Identifiers
- Product ID 71610-864_583b9556-795b-a4ca-e063-6294a90a4b68SPL ID 583b9556-795b-a4ca-e063-6294a90a4b68SPL set ID 25db7cc0-604c-3d6b-e063-6394a90a337fRxCUI 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
N471610086416followed by a unit qualifier and the quantityPackage 71610-0864-16. 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, USP is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with Tizanidine Tablets, USP should be reserved for those daily activities and times when relief of spasticity is most important [see Dosage and Administration(2.1) ]. Tizanidine Tablets, USP is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with Tizanidine Tablets, USP should be reserved for those daily activities and times when relief of spasticity is most important [ see Dosage and Administration (1) ].…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076416
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 4 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 57664-503 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 57664-502 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Direct_rx | 72189-602 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Proficient Rx LP | 71205-311 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1799 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Proficient Rx LP | 63187-673 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Medcore LLC | 82461-720 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Medcore LLC | 82461-721 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3181 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1016 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-325 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-326 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-338 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-327 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-339 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8533 |
| Tizanidine HCL | Tizanidine hydrochloride 4 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0022 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2371 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2370 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-7037 |
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