Quick answers
- What is Copaxone?
- Copaxone is a brand name of Glatiramer acetate, a prescription medicine. The FDA NDC Directory lists 2 Copaxone products in 2 strengths and forms.
- Who makes Copaxone?
- Teva Pharms USA holds the FDA application for Copaxone (NDA020622, approved December 20, 1996).
- Is there a generic or store brand of Copaxone?
- Yes. The FDA NDC Directory lists 16 other products with the same active ingredients, strength and form as a Copaxone product, 16 of them generic. Ask your pharmacist whether one is right for you.
- What do pharmacies pay for Copaxone?
- CMS lists a National Average Drug Acquisition Cost (NADAC) for 2 Copaxone strengths and forms (see the table below). That is what pharmacies pay to buy it, not what you pay: your price depends on your insurance and your pharmacy.
- Has Copaxone been recalled?
- FDA enforcement reports list 3 recalls of Copaxone products; the newest started October 24, 2013. A recall usually concerns specific lots, not every product.
What Copaxone is
Each Copaxone 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.
Glatiramer acetate · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| glatiramer acetate 20 mg/mL injection, solution (subcutaneous) | Copaxone | 8 products, 8 companies | DailyMed |
| glatiramer acetate 40 mg/mL injection, solution (subcutaneous) | Copaxone | 8 products, 8 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Glatiramer acetate →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA020622 | Teva Pharms USA | December 20, 1996 | 2 |
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 |
|---|---|---|
| glatiramer acetate 20 mg/mL injection, solution | Brand: Copaxone | $229.80 per mL Generic of the same strength and form: $39.67 per mL |
| glatiramer acetate 40 mg/mL injection, solution | Brand: Copaxone | $541.47 per mL Generic of the same strength and form: $82.23 per mL |
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 Copaxone
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Copaxone products.
- Teva Neuroscience, Inc.2 products
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
October 24, 2013 · Class II · Terminated · D-001-2014
Presence of Particulate Matter: A foreign particle found in a pre-filled syringe was reported through a consumer complaint about a pre-filled syringe.
Copaxone (glatiramer acetate injection), 20 mg/1 mL, 1 mL pre-filled syringe, packaged in 30 single-use PRE-FILLED Syringes and 33 Alcohol Preps (Swabs) per carton, Rx only, Marketed by: Teva Neuroscience, Inc., Kansas C — Teva Pharmaceuticals USA
-
December 5, 2012 · Class II · Terminated · D-249-2013
Presence of Foreign Substance: Product is being recalled due to receiving an elevated number of patient complaints related to a visible presence of medical grade silicone oil essential to the functionality of the syringe and plunger stopper system.
Copaxone (glatiramer acetate injection), 20 mg/1 mL, packaged in 30 single use PRE-FILLED syringes and 33 Alcohol Preps (swabs) per box, Marketed by: TEVA Neuroscience, Inc., Kansas City, MO 64131; Distributed by: TEVA P — Teva Pharmaceuticals USA, Inc.
-
May 18, 2012 · Class II · Terminated · D-1442-2012
Presence of Foreign Substance: Recall is being initiated due to the presence of a foreign particle identified from a customer complaint.
Copaxone (glatiramer acetate injection), 20mg/mL, 1 mL , Rx only, Marketed by: Teva Neuroscience - NDC 68546-317-30 — Teva Pharmaceuticals USA, Inc.
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.