Prescription drug · ANDA
Tizanidine HCL NDC 80425-0144
Tizanidine hydrochloride 4 mg/1 · Capsule · Oral · Advanced Rx Pharmacy of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0144-1 | 8042501440180425014401 | 30 CAPSULE in 1 BOTTLE (80425-0144-1)Marketed from Mar 29, 2019 | |
| 80425-0144-2 | 8042501440280425014402 | 60 CAPSULE in 1 BOTTLE (80425-0144-2)Marketed from Mar 29, 2019 | |
| 80425-0144-3 | 8042501440380425014403 | 90 CAPSULE in 1 BOTTLE (80425-0144-3)Marketed from Mar 29, 2019 | |
| 80425-0144-4 | 8042501440480425014404 | 120 CAPSULE in 1 BOTTLE (80425-0144-4)Marketed from Nov 17, 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 HCL
- Generic name (nonproprietary)
- tizanidine hcl
- Active ingredients
- Tizanidine hydrochloride — 4 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLCNDC labeler code 80425
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212196
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)
- Identifiers
- Product ID 80425-0144_43cfb518-01fc-0ea4-e063-6394a90a06d3SPL ID 43cfb518-01fc-0ea4-e063-6394a90a06d3SPL set ID c46c7aa3-69db-82dc-e053-2995a90ac251RxCUI 485485UNII 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
N480425014401followed by a unit qualifier and the quantityPackage 80425-0144-01. 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)
1. Indications and Usage Section 1 INDICATIONS & USAGE 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 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.
About NDC 80425-0144
- What is NDC 80425-0144?
- 80425-0144 is the product NDC for Tizanidine HCL, Tizanidine hydrochloride 4 mg/1 capsule, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tizanidine HCL.
- What is the active ingredient?
- Tizanidine hydrochloride.
- Who is the labeler?
- Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tizanidine HCL?
- 5 other product NDCs are listed under this name. See all Tizanidine HCL NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tizanidine HCL products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tizanidine HCl | Tizanidine hydrochloride 2 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0425 | 80425-0425-0180425-0425-0280425-0425-03 |
| Tizanidine HCL | Tizanidine hydrochloride 4 mg/1 | CapsuleOral | Advanced Rx of Tennessee, LLC | 80425-0090 | 80425-0090-0180425-0090-0280425-0090-03+1 more |
| Tizanidine HCL | Tizanidine hydrochloride 4 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0024 | 80425-0024-0180425-0024-0280425-0024-03+1 more |
| Tizanidine HCL | Tizanidine hydrochloride 4 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0022 | 80425-0022-0180425-0022-02 |
| Tizanidine HCl | Tizanidine hydrochloride 4 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0023 | 80425-0023-0180425-0023-0280425-0023-03+1 more |
Other NDCs under ANDA 212196
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 2 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-900 |
| Tizanidine Hydrochloride | Tizanidine hydrochloride 4 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-901 |
| Tizanidine Hydrochloride | Tizanidine hydrochloride 6 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-902 |
| Tizanidne hydrochloride | Tizanidine hydrochloride 2 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8871 |
| Tizanidne hydrochloride | Tizanidine hydrochloride 4 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8872 |
| Tizanidne hydrochloride | Tizanidine hydrochloride 6 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8873 |
| Tizanidne hydrochloride | Tizanidine hydrochloride 2 mg/1 | CapsuleOral | Ascend Laboratories, LLC | 67877-610 |
| Tizanidne hydrochloride | Tizanidine hydrochloride 4 mg/1 | CapsuleOral | Ascend Laboratories, LLC | 67877-611 |
| Tizanidne hydrochloride | Tizanidine hydrochloride 6 mg/1 | CapsuleOral | Ascend Laboratories, LLC | 67877-612 |
| Tizanidne hydrochloride | Tizanidine hydrochloride 4 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8798 |
| Tizanidne hydrochloride | Tizanidine hydrochloride 6 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2077 |
| Tizanidne hydrochloride | Tizanidine hydrochloride 2 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2208 |
| Tizanidne hydrochloride | Tizanidine hydrochloride 4 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2209 |
| Tizanidne hydrochloride | Tizanidine hydrochloride 6 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2210 |
| Tizanidne hydrochloride | Tizanidine hydrochloride 2 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-1860 |
| Tizanidne hydrochloride | Tizanidine hydrochloride 4 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-1861 |
| Tizanidne hydrochloride | Tizanidine hydrochloride 6 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-1862 |
| Tizanidne hydrochloride | Tizanidine hydrochloride 6 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-231 |