Prescription drug · ANDA
Tizanidine NDC 76420-338
Tizanidine hydrochloride 2 mg/1 · Tablet · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-338-00 | 76420033800 | 1000 TABLET in 1 BOTTLE (76420-338-00)Marketed from May 2, 2025 | |
| 76420-338-15 | 76420033815 | 150 TABLET in 1 BOTTLE (76420-338-15)Marketed from May 2, 2025 | |
| 76420-338-30 | 76420033830 | 30 TABLET in 1 BOTTLE (76420-338-30)Marketed from May 2, 2025 | |
| 76420-338-60 | 76420033860 | 60 TABLET in 1 BOTTLE (76420-338-60)Marketed from May 2, 2025 | |
| 76420-338-90 | 76420033890 | 90 TABLET in 1 BOTTLE (76420-338-90)Marketed from May 2, 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 — 2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Asclemed USA, Inc.
- 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 76420-338_3423349e-5bea-b5eb-e063-6394a90a6241SPL ID 3423349e-5bea-b5eb-e063-6394a90a6241SPL set ID 2f460275-565f-4737-a3df-bf80b9acc268RxCUI 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
N476420033800followed by a unit qualifier and the quantityPackage 76420-0338-00. 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 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 | Aphena Pharma Solutions - Tennessee, LLC | 71610-864 |
| 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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