Prescription drug · ANDA
Glatiramer Acetate (glatiramer) NDC 0378-6961
Glatiramer acetate 40 mg/mL · Injection, Solution · Subcutaneous · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-6961-12 | 00378696112 | 12 BLISTER PACK in 1 CARTON (0378-6961-12) / 1 SYRINGE in 1 BLISTER PACK (0378-6961-32) / 1 mL in 1 SYRINGEMarketed from Oct 4, 2017 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Glatiramer Acetate
- Generic name (nonproprietary)
- glatiramer
- Active ingredients
- Glatiramer acetate — 40 mg/mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Mylan Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206936
- Marketing start
- Listing expires
- Identifiers
- Product ID 0378-6961_f5070abd-2219-47fa-8ff2-c0b147ea3eb7SPL ID f5070abd-2219-47fa-8ff2-c0b147ea3eb7SPL set ID 456a34c7-8511-4000-99a7-ad8f8de6d35eRxCUI 1487361UNII 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
N400378696112followed by a unit qualifier and the quantityPackage 00378-6961-12. 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)
Glatiramer acetate injection 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. Glatiramer acetate injection 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.