Prescription drug · NDA
Copaxone (Glatiramer acetate) NDC 68546-325
Glatiramer acetate 40 mg/mL · Injection, Solution · Subcutaneous · Teva Neuroscience, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68546-325-06 | 6854603250668546032506 | 6 BLISTER PACK in 1 CARTON (68546-325-06) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASSMarketed from Jan 29, 2014 | |
| 68546-325-12 | 6854603251268546032512 | 12 BLISTER PACK in 1 CARTON (68546-325-12) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASSMarketed from Jan 29, 2014 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Copaxone
- Generic name (nonproprietary)
- glatiramer acetate
- Active ingredients
- Glatiramer acetate — 40 mg/mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Teva Neuroscience, Inc.NDC labeler code 68546
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020622
- Marketing start
- Listing expires
- Identifiers
- Product ID 68546-325_11a58ba0-b865-49e6-86e3-eb9bb58341e5SPL ID 11a58ba0-b865-49e6-86e3-eb9bb58341e5SPL set ID aa88f583-4f5f-433b-80b4-1f4c9fb28357RxCUI 1111641, 1111642, 1487361, 1487363UNII 5M691HL4BO
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N468546032506followed by a unit qualifier and the quantityPackage 68546-0325-06. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
COPAXONE is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. COPAXONE is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults ( 1 ).
Excerpt only. Read the full label for complete information.
About NDC 68546-325
- What is NDC 68546-325?
- 68546-325 is the product NDC for Copaxone (glatiramer acetate), Glatiramer acetate 40 mg/mL injection, solution, listed with the FDA by Teva Neuroscience, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Copaxone (Glatiramer Acetate).
- What is the active ingredient?
- Glatiramer acetate.
- Who is the labeler?
- Teva Neuroscience, Inc., NDC labeler code 68546. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Copaxone?
- 1 other product NDC are listed under this name. See all Copaxone NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Copaxone products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Copaxoneglatiramer acetate | Glatiramer acetate 20 mg/mL | Injection, SolutionSubcutaneous | Teva Neuroscience, Inc. | 68546-317 | 68546-0317-30 |
Other NDCs under NDA 020622
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Copaxoneglatiramer acetate | Glatiramer acetate 20 mg/mL | Injection, SolutionSubcutaneous | Teva Neuroscience, Inc. | 68546-317 |