Quick answers
- What is Zanaflex?
- Zanaflex is a brand name of Tizanidine, a prescription medicine. The FDA NDC Directory lists 9 Zanaflex products in 5 strengths and forms.
- Who makes Zanaflex?
- Legacy holds the FDA application for Zanaflex (NDA020397, approved November 27, 1996). 2 other companies (repackagers or distributors) also list Zanaflex products.
- Is there a generic or store brand of Zanaflex?
- Yes. The FDA NDC Directory lists 135 other products with the same active ingredients, strength and form as a Zanaflex product, 135 of them generic. Ask your pharmacist whether one is right for you.
- Has Zanaflex been recalled?
- No recall linked to Zanaflex products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Zanaflex is
Each Zanaflex product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Tizanidine · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| tizanidine hydrochloride 2 mg capsule (oral) | Zanaflex | 16 products, 14 companies | DailyMed |
| tizanidine hydrochloride 4 mg capsule (oral) | Zanaflex | 23 products, 17 companies | DailyMed |
| tizanidine hydrochloride 4 mg tablet (oral) | Zanaflex | 69 products, 36 companies | DailyMed |
| tizanidine hydrochloride 6 mg capsule (oral) | Zanaflex | 25 products, 18 companies | DailyMed |
| tizanidine hydrochloride 8 mg capsule (oral) | Zanaflex | 2 products, 2 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Tizanidine →
FDA approval
- 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 | Holder | First approved | Products |
|---|---|---|---|
| NDA020397 | Legacy | November 27, 1996 | 2 |
| NDA021447 | Legacy | August 29, 2002 | 6 |
| ANDA213798 | Rubicon Research | May 27, 2020 | 1 |
Companies that list Zanaflex
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Zanaflex products.
- Legacy Pharma USA, Inc.4 products
- Covis Pharma US, Inc4 products
- Trifluent Pharma, LLC1 product
Recalls
No recall linked to Zanaflex products (by their NDC code or label) appears in the FDA enforcement reports.
Sources
- 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 labeling (SPL, 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
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.