Prescription drug · ANDA
Tizanidine Hydrochloride NDC 80425-0448
Tizanidine hydrochloride 6 mg/1 · Capsule · Oral · Advanced Rx of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0448-1 | 80425044801 | 30 CAPSULE in 1 BOTTLE, PLASTIC (80425-0448-1)Marketed from Oct 29, 2024 | |
| 80425-0448-2 | 80425044802 | 60 CAPSULE in 1 BOTTLE, PLASTIC (80425-0448-2)Marketed from Oct 29, 2024 | |
| 80425-0448-3 | 80425044803 | 90 CAPSULE in 1 BOTTLE, PLASTIC (80425-0448-3)Marketed from Oct 29, 2024 |
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 Hydrochloride
- Generic name (nonproprietary)
- tizanidine hydrochloride
- Active ingredients
- Tizanidine hydrochloride — 6 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210267
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)
- Identifiers
- Product ID 80425-0448_26f91e07-2e12-1faf-e063-6394a90a0eb4SPL ID 26f91e07-2e12-1faf-e063-6394a90a0eb4SPL set ID 26f8f233-5dc2-0013-e063-6394a90ab0f5RxCUI 485484UNII 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
N480425044801followed by a unit qualifier and the quantityPackage 80425-0448-01. 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 hydrochloride is indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine hydrochloride capsules should be reserved for those daily activities and times when relief of spasticity is most important [see Dosage and Administration (2.1) ] . Tizanidine hydrochloride is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with Tizanidine hydrochloride capsules 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 210267
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 Hydrochloride | Tizanidine hydrochloride 6 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-9743 |
| Tizanidine Hydrochloride | Tizanidine hydrochloride 4 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8747 |
| Tizanidine Hydrochloride | Tizanidine hydrochloride 2 mg/1 | CapsuleOral | Ingenus Pharmaceuticals, LLC | 50742-224 |
| Tizanidine Hydrochloride | Tizanidine hydrochloride 4 mg/1 | CapsuleOral | Ingenus Pharmaceuticals, LLC | 50742-225 |
| Tizanidine Hydrochloride | Tizanidine hydrochloride 6 mg/1 | CapsuleOral | Ingenus Pharmaceuticals, LLC | 50742-226 |
| Tizanidine Hydrochloride | Tizanidine hydrochloride 6 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8478 |
| Tizanidine | Tizanidine hydrochloride 6 mg/1 | CapsuleOral | Direct_Rx | 72189-526 |
| Tizanidine Hydrochloride | Tizanidine hydrochloride 6 mg/1 | CapsuleOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-892 |
| Tizanidine HCL | Tizanidine hydrochloride 4 mg/1 | CapsuleOral | Advanced Rx of Tennessee, LLC | 80425-0090 |