Copaxone (glatiramer acetate) NDC 68546-317

NDC codes

FDA NDC Directory

Product NDC (as listed)68546-317Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68546-0317Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
68546-317-30	68546031730	30 BLISTER PACK in 1 CARTON (68546-317-30) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASSMarketed from Apr 28, 2008

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 — 20 mg/mL
Dosage form: Injection, Solution
Route: Subcutaneous
Labeler: Teva Neuroscience, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 020622
Marketing start: Apr 28, 2008
Listing expires: Dec 31, 2027
Identifiers: Product ID 68546-317_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.

How CPT relates to drug billing

NDC on a medical claim

N468546031730 followed by a unit qualifier and the quantity

Package 68546-0317-30. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under NDA 020622

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 020622
Product	Strength	Form · route	Labeler	Product NDC
Copaxoneglatiramer acetate	Glatiramer acetate 40 mg/mL	Injection, SolutionSubcutaneous	Teva Neuroscience, Inc.	68546-325