Quick answers
- What is Tizanidine used for?
- The FDA-approved label (Zanaflex, Legacy Pharma USA, Inc., January 2, 2026) says: “Zanaflex is indicated for the treatment of spasticity in adults. Zanaflex is a central alpha-2-adrenergic agonist indicated for the treatment of spasticity.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Tizanidine have a boxed warning?
- No. None of the 126 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Tizanidine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Tizanidine been recalled?
- FDA enforcement reports list 8 recalls of products of this medicine; the newest started January 2, 2024 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Tizanidine?
- 50 companies list prescription products of Tizanidine in the FDA NDC Directory, including Bryant Ranch Prepack, Asclemed USA, Inc. and Advanced Rx of Tennessee, LLC.
What Tizanidine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Zanaflex is indicated for the treatment of spasticity in adults. Zanaflex is a central alpha-2-adrenergic agonist indicated for the treatment of spasticity.
— FDA label: Zanaflex, Legacy Pharma USA, Inc., effective January 2, 2026. Read the full label on DailyMed →
The FDA has 126 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 126 FDA labels for this medicine have a boxed warning.
Forms and how it is given
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| tizanidine hydrochloride 2 mg capsule | Generic | $0.0898 per capsule |
| tizanidine hydrochloride 2 mg capsule, gelatin coated | Generic | $0.0898 per capsule |
| tizanidine hydrochloride 2 mg tablet | Generic | $0.0323 per tablet |
| tizanidine hydrochloride 4 mg capsule | Generic | $0.1013 per capsule |
| tizanidine hydrochloride 4 mg capsule, gelatin coated | Generic | $0.1013 per capsule |
| tizanidine hydrochloride 4 mg tablet | Generic | $0.0338 per tablet |
| tizanidine hydrochloride 6 mg capsule | Generic | $0.1436 per capsule |
| tizanidine hydrochloride 6 mg capsule, gelatin coated | Generic | $0.1436 per capsule |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack27 products
- Asclemed USA, Inc.12 products
- Advanced Rx of Tennessee, LLC9 products
- Preferred Pharmaceuticals Inc.9 products
- A-S Medication Solutions8 products
- PD-Rx Pharmaceuticals, Inc.8 products
- Remedyrepack Inc.7 products
- Proficient Rx LP6 products
- Direct_Rx5 products
- Zydus Lifesciences Limited5 products
- Ascend Laboratories, LLC5 products
- Aurobindo Pharma Limited5 products
- Apotex Corp.5 products
- Aphena Pharma Solutions - Tennessee, LLC4 products
- Legacy Pharma USA Inc.4 products
- NuCare Pharmaceuticals, Inc.4 products
- Covis Pharma US, Inc4 products
- Advagen Pharma Limited4 products
- Advanced Rx Pharmacy of Tennessee, LLC4 products
- Actavis Pharma, Inc.3 products
- Alembic Pharmaceuticals Limited3 products
- Ingenus Pharmaceuticals, LLC3 products
- Modavar Pharmaceuticals LLC3 products
- Zydus Pharmaceuticals USA Inc.3 products
- Cadila Pharmaceuticals Limited3 products
- Redpharm Drug3 products
- Alembic Pharmaceuticals Inc.3 products
- Kanchan Healthcare Inc3 products
- St. Mary's Medical Park Pharmacy3 products
- NorthStar Rx LLC2 products
- Unichem Pharmaceuticals (USA), Inc.2 products
- Sun Pharmaceutical Industries, Inc.2 products
- Northwind Health Company, LLC2 products
- Viona Pharmaceuticals Inc2 products
- NCS HealthCare of KY, LLC dba Vangard Labs2 products
- Hawaii Repack, Inc.2 products
- Dr. Reddy's Laboratories Limited2 products
- Medcore LLC2 products
- Rising Pharma Holdings, Inc.2 products
- American Health Packaging2 products
- Quality Care Products, LLC2 products
- Trifluent Pharma, LLC2 products
- AvPAK2 products
- Phoenix RX LLC1 product
- Major Pharmaceuticals1 product
- Tizanidine Hydrochloride1 product
- Coupler LLC1 product
- Rosemont Pharmaceuticals LLC1 product
- AvKARE1 product
- Cardinal Health 107, LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020397 ZANAFLEX | Legacy | November 27, 1996 | 20, latest November 22, 2024 2024: Labeling · 2024: Labeling · 2016: Manufacturing (CMC) |
| NDA021447 ZANAFLEX | Legacy | August 29, 2002 | 6, latest November 22, 2024 2024: Labeling · 2020: Labeling · 2014: Manufacturing (CMC) |
| NDA216190 ONTRALFY | Fidelity Biopharma | December 12, 2024 | — |
Generic approvals (16)
- ANDA076286DR Reddys Labs Inc · July 3, 2002
- ANDA076416Sun Pharm Inds Inc · September 29, 2003
- ANDA076282Aurobindo Pharma USA · December 16, 2003
- ANDA076533Apotex · January 16, 2004
- ANDA078868Apotex Inc · February 3, 2012
- ANDA091283Unichem Labs Ltd · November 28, 2012
- ANDA208622Zydus Pharms · March 3, 2017
- ANDA208187Cadila · March 9, 2018
- ANDA211798Alkem Labs Ltd · January 25, 2019
- ANDA210267Ingenus Pharms LLC · March 12, 2019
- ANDA210021Cadila Pharms Ltd · March 26, 2019
- ANDA212196Alkem Labs Ltd · March 27, 2019
- ANDA213223Alembic · January 13, 2020
- ANDA213544Aurobindo Pharma Ltd · March 24, 2020
- ANDA213798Rubicon Research · May 27, 2020
- ANDA218920Rising · August 7, 2024
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
January 2, 2024 · Class II · Completed · D-0223-2024
Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets.
Tizanidine Tablets, USP 4mg, 150-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-180-15 — Dr. Reddy's Laboratories, Inc.
-
June 26, 2023 · Class II · Ongoing · D-0894-2023
Failed Stability Specifications
Tizanidine Hydrochloride Tablet 4mg, packaged in a) 20 count-bottles (NDC 68788-7781-2), b)30-count bottles (NDC: 68788-7781-3), c) 60-count bottles, (NDC: 68788-7781-6), d) 90-count bottles (NDC: 68788-7781-9), e) 120-c — Preferred Pharmaceuticals, Inc.
-
June 23, 2023 · Class II · Terminated · D-0892-2023
Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Reddy's Laboratories, Inc., due to out of specification results for dissolution.
Tizanidine Tablets, USP, 4 mg, 100 Tablets (10 tablets x 10 unit dose blister packs) per carton, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-645-01 (carton), barcode ( — Amerisource Health Services LLC
-
June 21, 2023 · Class II · Ongoing · D-0923-2023
Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.
Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Srikakulam - 532 409 India. NDC 55111-180-10 — Dr Reddy's Laboratories Limited
-
July 19, 2021 · Class II · Terminated · D-0750-2021
Failed Tablet/Capsule Specification: Some tablets are shaved
Tizanidine HCl Tablets, USP 4 mg, 150-count bottles, Rx only, Mfd By: Dr. Reddy's Laboratories limited, Srikakulam District, 532 409 INDIA, NDC 55111-180-15. — Dr. Reddy's Laboratories, Inc.
-
November 24, 2020 · Class II · Terminated · D-0173-2021
Failed Dissolution Specifications; Out of Specification (low) results were obtained.
Tizanidine Tablets, USP 4mg, Rx Only, 150 Tablets per Bottle, Manufactured by Alkem Laboratories Ltd, Mumbai - 400 013, INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC: 67877-614-15. — Ascend Laboratories LLC
-
September 4, 2018 · Class II · Terminated · D-1191-2018
Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of Tinzadine Hcl Tablets .
Tizanidine HCl Tablets, USP 2mg, 150-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited Srilakulam - 532 409 INDIA, NDC 55111-179-15, UPC 35511179153 — Dr. Reddy's Laboratories, Inc.
-
March 19, 2013 · Class III · Terminated · D-238-2013
Labeling Illegible: There is a possibility that the bottle labels do not contain the strength of the product as well as other printing details.
Tizanidine Tablets USP, 4 mg, 150-count tablets per bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachepally - 500 090 India; NDC 55111-180-15. — Dr. Reddy'S Laboratories
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Zanaflex, Legacy Pharma USA, Inc., effective January 2, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →