Prescription drug · ANDA
tizanidine NDC 68071-3719
Tizanidine hydrochloride 4 mg/1 · Tablet · Oral · NuCare Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-3719-3 | 68071371903 | 30 TABLET in 1 BOTTLE (68071-3719-3)Marketed from Nov 13, 2024 | |
| 68071-3719-9 | 68071371909 | 90 TABLET in 1 BOTTLE (68071-3719-9)Marketed from Jan 14, 2025 |
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
- NuCare 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 68071-3719_2bae2620-0abb-7e55-e063-6394a90ad47cSPL ID 2bae2620-0abb-7e55-e063-6394a90ad47cSPL set ID 26cffb1f-21a0-017f-e063-6394a90afb1aRxCUI 313413UNII B53E3NMY5CUPC 0368071371932
- 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
N468071371903followed by a unit qualifier and the quantityPackage 68071-3719-03. 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 management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine tablets should be reserved for those daily activities and times when relief of spasticity is most important. ( 1 ) Tizanidine tablets are indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine tablets 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 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 4 mg/1 | TabletOral | Coupler LLC | 67046-1444 |
| tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-885 |
| tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8469 |
| 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 | 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 2 mg/1 | TabletOral | Viona Pharmaceuticals Inc | 72578-096 |
| 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 2 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8468 |