Prescription drug · ANDA
Glatiramer Acetate (Glatiramer acetate injection) NDC 0832-6085
Glatiramer acetate 40 mg/mL · Injection, Solution · Subcutaneous · UPSHER-SMITH LABORATORIES, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0832-6085-12 | 0083260851200832608512 | 12 SYRINGE, GLASS in 1 CARTON (0832-6085-12) / 1 mL in 1 SYRINGE, GLASS (0832-6085-89)Marketed from Jan 23, 2026 |
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 acetate injection
- Active ingredients
- Glatiramer acetate — 40 mg/mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- UPSHER-SMITH LABORATORIES, LLCNDC labeler code 0832
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214741
- Marketing start
- Listing expires
- Identifiers
- Product ID 0832-6085_991aa361-3f99-42cd-948b-5b1271b346c5SPL ID 991aa361-3f99-42cd-948b-5b1271b346c5SPL set ID 707a64ef-964e-44a3-8a0f-fcc2eb5b1af2RxCUI 1111641, 1487361UNII 5M691HL4BOUPC 0308326084309, 0308326085122
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
N400832608512followed by a unit qualifier and the quantityPackage 00832-6085-12. 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.
About NDC 0832-6085
- What is NDC 0832-6085?
- 0832-6085 is the product NDC for Glatiramer Acetate (glatiramer acetate injection), Glatiramer acetate 40 mg/mL injection, solution, listed with the FDA by UPSHER-SMITH LABORATORIES, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Glatiramer Acetate (Glatiramer Acetate Injection).
- What is the active ingredient?
- Glatiramer acetate.
- Who is the labeler?
- UPSHER-SMITH LABORATORIES, LLC, NDC labeler code 0832. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Glatiramer Acetate?
- 11 other product NDCs are listed under this name. See all Glatiramer Acetate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Glatiramer Acetate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Glatiramer Acetate | Glatiramer acetate 20 mg/mL | Injection, SolutionSubcutaneous | AJENAT PHARMACEUTICALS LLC | 82983-429 | 82983-0429-30 |
| Glatiramer Acetate | Glatiramer acetate 40 mg/mL | Injection, SolutionSubcutaneous | AJENAT PHARMACEUTICALS LLC | 82983-430 | 82983-0430-12 |
| Glatiramer Acetateglatiramer acetate injection | Glatiramer acetate 20 mg/mL | Injection, SolutionSubcutaneous | UPSHER-SMITH LABORATORIES, LLC | 0832-6084 | 00832-6084-30 |
| Glatiramer Acetate | Glatiramer acetate 20 mg/mL | Injection, SolutionSubcutaneous | Italfarmaco SpA | 11797-764 | 11797-0764-03 |
| Glatiramer Acetate | Glatiramer acetate 40 mg/mL | Injection, SolutionSubcutaneous | Italfarmaco SpA | 11797-765 | 11797-0765-03 |
| Glatiramer Acetate | Glatiramer acetate 20 mg/mL | Injection, SolutionSubcutaneous | Zydus Pharmaceuticals USA Inc. | 70710-1548 | 70710-1548-09 |
| Glatiramer Acetate | Glatiramer acetate 40 mg/mL | Injection, SolutionSubcutaneous | Zydus Pharmaceuticals USA Inc. | 70710-1549 | 70710-1549-06 |
| Glatiramer Acetate | Glatiramer acetate 20 mg/mL | Injection, SolutionSubcutaneous | Sun Pharmaceutical Industries, Inc. | 47335-990 | 47335-0990-02 |
| Glatiramer Acetate | Glatiramer acetate 40 mg/mL | Injection, SolutionSubcutaneous | Sun Pharmaceutical Industries, Inc. | 47335-991 | 47335-0991-02 |
| Glatiramer Acetate | Glatiramer acetate 20 mg/mL | Injection, SolutionSubcutaneous | Mylan Pharmaceuticals Inc. | 0378-6960 | 00378-6960-93 |
Other NDCs under ANDA 214741
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 |
|---|---|---|---|---|
| Glatiramer Acetateglatiramer acetate injection | Glatiramer acetate 20 mg/mL | Injection, SolutionSubcutaneous | UPSHER-SMITH LABORATORIES, LLC | 0832-6084 |