Prescription drug · ANDA
Glatopa (Glatiramer acetate) NDC 0781-3250
Glatiramer acetate 40 mg/mL · Injection, Solution · Subcutaneous · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0781-3250-89 | 0078132508900781325089 | 12 BLISTER PACK in 1 CARTON (0781-3250-89) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS (0781-3250-71)Marketed from Feb 12, 2018 |
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)
- Glatopa
- Generic name (nonproprietary)
- glatiramer acetate
- Active ingredients
- Glatiramer acetate — 40 mg/mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Sandoz IncNDC labeler code 0781
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206921
- Marketing start
- Listing expires
- Identifiers
- Product ID 0781-3250_104fa47b-517a-44aa-9308-55c97679540bSPL ID 104fa47b-517a-44aa-9308-55c97679540bSPL set ID 5f01e40a-b6f6-40fb-b37c-3d06f1428e86RxCUI 1111641, 1487361, 1654630, 2000007UNII 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
N400781325089followed by a unit qualifier and the quantityPackage 00781-3250-89. 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)
Glatopa 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. Glatopa 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 0781-3250
- What is NDC 0781-3250?
- 0781-3250 is the product NDC for Glatopa (glatiramer acetate), Glatiramer acetate 40 mg/mL injection, solution, listed with the FDA by Sandoz Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Glatopa (Glatiramer Acetate).
- What is the active ingredient?
- Glatiramer acetate.
- Who is the labeler?
- Sandoz Inc, NDC labeler code 0781. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Glatopa?
- 3 other product NDCs are listed under this name. See all Glatopa NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Glatopa products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Glatopaglatiramer acetate | Glatiramer acetate 40 mg/mL | Injection, SolutionSubcutaneous | Bryant Ranch Prepack | 63629-8816 | 63629-8816-01 |
| Glatopaglatiramer acetate | Glatiramer acetate 20 mg/mL | Injection, SolutionSubcutaneous | Sandoz Inc | 0781-3234 | 00781-3234-34 |
| Glatopaglatiramer acetate | Glatiramer acetate 20 mg/mL | Injection, SolutionSubcutaneous | Bryant Ranch Prepack | 63629-8815 | 63629-8815-01 |
Other NDCs under ANDA 206921
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 |
|---|---|---|---|---|
| Glatopaglatiramer acetate | Glatiramer acetate 40 mg/mL | Injection, SolutionSubcutaneous | Bryant Ranch Prepack | 63629-8816 |