NDC 68546-325 – Copaxone
Glatiramer Acetate 40 mg/mL · Injection, Solution · Subcutaneous
Product NDC68546-325
Product details
- Brand name
- Copaxone
- Generic name
- Glatiramer Acetate
- Labeler
- Teva Neuroscience, Inc.
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Marketing category
- NDA · NDA020622
- Marketed since
- January 29, 2014
- Listing expires
- December 31, 2027
Active ingredients
- Glatiramer Acetate 40 mg/mL
Package NDC codes (2)
| Package NDC | Description | Since |
|---|---|---|
| 68546-325-06 | 6 BLISTER PACK in 1 CARTON (68546-325-06) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS | Jan 29, 2014 |
| 68546-325-12 | 12 BLISTER PACK in 1 CARTON (68546-325-12) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS | Jan 29, 2014 |
Recalls mentioning this NDC
- D-001-2014 Nov 27, 2013 · Class II
Presence of Particulate Matter: A foreign particle found in a pre-filled syringe was reported through a consumer complaint about a pre-filled syringe. - D-249-2013 Apr 24, 2013 · Class II
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… - D-1442-2012 Aug 15, 2012 · Class II
Presence of Foreign Substance: Recall is being initiated due to the presence of a foreign particle identified from a customer complaint.
Other Copaxone products
- 68546-317 Glatiramer Acetate 20 mg/mL · Injection, Solution · Teva Neuroscience, Inc.