Prescription drug · ANDA
Tizanidine NDC 68084-645
Tizanidine hydrochloride 4 mg/1 · Tablet · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68084-645-01 | 68084064501 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-645-01) / 1 TABLET in 1 BLISTER PACK (68084-645-11)Marketed from Oct 1, 2013 | |
| 68084-645-65 | 68084064565 | 50 BLISTER PACK in 1 CARTON (68084-645-65) / 1 TABLET in 1 BLISTER PACK (68084-645-11)Marketed from Dec 15, 2023 |
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
- Labeler
- American Health Packaging
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076286
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)
- Identifiers
- Product ID 68084-645_35bfea02-ba73-d8c2-e063-6394a90a5c9fSPL ID 35bfea02-ba73-d8c2-e063-6394a90a5c9fSPL set ID 3670f9e3-988d-48e6-9df0-d403d699e08aRxCUI 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
N468084064501followed by a unit qualifier and the quantityPackage 68084-0645-01. 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 tablet 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 should be reserved for those daily activities and times when relief of spasticity is most important [see Dosage and Administration (2.1) ]. Tizanidine tablet is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine tablet should be reserved for those daily activities and times when relief of spasticity is most important. (1)
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076286
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 | 50090-6756 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7991 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-3209 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-228 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-229 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-694 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3112 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Dr. Reddy's Laboratories Limited | 55111-179 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | A-S Medication Solutions | 50090-0811 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Dr. Reddy's Laboratories Limited | 55111-180 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | NorthStar Rx LLC | 16714-171 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | NorthStar Rx LLC | 16714-172 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | A-S Medication Solutions | 50090-0840 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-603 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | PHOENIX RX LLC | 85509-1180 |
| Tizanidine Hydrochloride | Tizanidine hydrochloride 4 mg/1 | TabletOral | Quality Care Products LLC | 49999-347 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-455 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | American Health Packaging | 68084-775 |
| Tizanidine HCl | Tizanidine hydrochloride 4 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0023 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-5268 |
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