Prescription drug · ANDA
Tizanidine NDC 70518-1598
Tizanidine hydrochloride 4 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-1598-1 | 70518159801 | 60 TABLET in 1 BOTTLE, PLASTIC (70518-1598-1)Marketed from Aug 1, 2019 | |
| 70518-1598-3 | 70518159803 | 30 TABLET in 1 BOTTLE, PLASTIC (70518-1598-3)Marketed from Mar 6, 2020 | |
| 70518-1598-4 | 70518159804 | 90 TABLET in 1 BOTTLE, PLASTIC (70518-1598-4)Marketed from Apr 3, 2020 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091283
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)
- Identifiers
- Product ID 70518-1598_561da0d9-88b4-95d0-e063-6394a90ac769SPL ID 561da0d9-88b4-95d0-e063-6394a90ac769SPL set ID b14bd166-9f53-4f2e-be05-c447af04ef69RxCUI 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
N470518159801followed by a unit qualifier and the quantityPackage 70518-1598-01. 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 is a central alpha-2-adrenergic agonist indicated for the treatment of spasticity. ( 1 ) Tizanidine is indicated for the treatment of spasticity in adults.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091283
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 | A-S Medication Solutions | 50090-7889 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4463 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0187 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-868 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8802 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-168 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-169 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0424 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | A-S Medication Solutions | 50090-2078 |
| Tizanidine Hydrochloride | Tizanidine hydrochloride 4 mg/1 | TabletOral | TIZANIDINE HYDROCHLORIDE | 61919-196 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Redpharm Drug | 67296-2209 |
| Tizanidine HCL | Tizanidine hydrochloride 4 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0024 |
| Tizandine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Direct_Rx | 61919-811 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-228 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Proficient Rx LP | 63187-493 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | A-S Medication Solutions | 50090-5767 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Proficient Rx LP | 63187-910 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0914 |