Prescription drug · ANDA
Tizandine NDC 61919-811
Tizanidine hydrochloride 2 mg/1 · Tablet · Oral · Direct_Rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61919-811-82 | 61919081182 | 180 TABLET in 1 BOTTLE (61919-811-82)Marketed from Aug 13, 2019 | |
| 61919-811-90 | 61919081190 | 90 TABLET in 1 BOTTLE (61919-811-90)Marketed from Aug 13, 2019 |
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)
- Tizandine
- Generic name (nonproprietary)
- tizandine
- Active ingredients
- Tizanidine hydrochloride — 2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Direct_Rx
- 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 61919-811_4c49db13-77a7-a9db-e063-6294a90a3197SPL ID 4c49db13-77a7-a9db-e063-6294a90a3197SPL set ID 9003cb5d-f9d6-7183-e053-2995a90ad6e8RxCUI 313412UNII 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
N461919081182followed by a unit qualifier and the quantityPackage 61919-0811-82. 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 management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most important [see Dosage and Administration (2.1)].
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 |
| 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 | REMEDYREPACK INC. | 70518-1598 |
| 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 |