Teva Neuroscience, Inc.
NDC labeler code: 68546
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- DeutetrabenazineAustedo XR, Austedo · 11 products
- Glatiramer acetateGlatopa, Copaxone · 2 products
- RasagilineAzilect · 2 products
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| February 17, 2023 | NDA216354 | Deutetrabenazine AUSTEDO XR | Teva |
| April 3, 2017 | NDA208082 | Deutetrabenazine AUSTEDO | Teva Branded Pharm |
| May 16, 2006 | NDA021641 | Rasagiline AZILECT | Teva |
| December 20, 1996 | NDA020622 | Glatiramer acetate COPAXONE | Teva Pharms USA |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2013
-
October 24, 2013 · Class II · Terminated · D-001-2014 · Glatiramer acetate
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
2012
-
December 5, 2012 · Class II · Terminated · D-249-2013 · Glatiramer acetate
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
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May 18, 2012 · Class II · Terminated · D-1442-2012 · Glatiramer acetate
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
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).
Next steps
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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 recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026