Prescription drug · ANDA
Glatiramer Acetate NDC 82983-430
Glatiramer acetate 40 mg/mL · Injection, Solution · Subcutaneous · AJENAT PHARMACEUTICALS LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82983-430-12 | 8298304301282983043012 | 12 BLISTER PACK in 1 CARTON (82983-430-12) / 1 SYRINGE in 1 BLISTER PACK (82983-430-01) / 1 mL in 1 SYRINGEMarketed from Mar 20, 2026 |
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)
- Glatiramer Acetate
- Generic name (nonproprietary)
- glatiramer acetate
- Active ingredients
- Glatiramer acetate — 40 mg/mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- AJENAT PHARMACEUTICALS LLCNDC labeler code 82983
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214022
- Marketing start
- Listing expires
- Identifiers
- Product ID 82983-430_ec371b5b-1ec4-4eaa-8f5e-2c06f5965a2eSPL ID ec371b5b-1ec4-4eaa-8f5e-2c06f5965a2eSPL set ID 1ec10223-880d-402f-a759-9cd179bf09deRxCUI 1487361UNII 5M691HL4BOUPC 0382983430129, 0382983430013
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
N482983043012followed by a unit qualifier and the quantityPackage 82983-0430-12. 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 82983-430
- What is NDC 82983-430?
- 82983-430 is the product NDC for Glatiramer Acetate, Glatiramer acetate 40 mg/mL injection, solution, listed with the FDA by AJENAT PHARMACEUTICALS LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Glatiramer Acetate.
- What is the active ingredient?
- Glatiramer acetate.
- Who is the labeler?
- AJENAT PHARMACEUTICALS LLC, NDC labeler code 82983. 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 Acetateglatiramer acetate injection | Glatiramer acetate 20 mg/mL | Injection, SolutionSubcutaneous | UPSHER-SMITH LABORATORIES, LLC | 0832-6084 | 00832-6084-30 |
| Glatiramer Acetateglatiramer acetate injection | Glatiramer acetate 40 mg/mL | Injection, SolutionSubcutaneous | UPSHER-SMITH LABORATORIES, LLC | 0832-6085 | 00832-6085-12 |
| 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 |