Prescription drug · ANDA
Glatiramer Acetate NDC 0378-6960
Glatiramer acetate 20 mg/mL · Injection, Solution · Subcutaneous · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-6960-93 | 0037869609300378696093 | 30 BLISTER PACK in 1 CARTON (0378-6960-93) / 1 SYRINGE in 1 BLISTER PACK (0378-6960-32) / 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 acetate
- Active ingredients
- Glatiramer acetate — 20 mg/mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Mylan Pharmaceuticals Inc.NDC labeler code 0378
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091646
- Marketing start
- Listing expires
- Identifiers
- Product ID 0378-6960_b7562df3-2e18-4454-83e9-e0ebaccf25a9SPL ID b7562df3-2e18-4454-83e9-e0ebaccf25a9SPL set ID f38b5606-d2d7-44ec-912f-46882aa2fa7bRxCUI 1111641UNII 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
N400378696093followed by a unit qualifier and the quantityPackage 00378-6960-93. 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 0378-6960
- What is NDC 0378-6960?
- 0378-6960 is the product NDC for Glatiramer Acetate, Glatiramer acetate 20 mg/mL injection, solution, listed with the FDA by Mylan Pharmaceuticals Inc.. 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?
- Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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 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 |