Prescription drug · ANDA
Glatopa (glatiramer acetate) NDC 63629-8816
Glatiramer acetate 40 mg/mL · Injection, Solution · Subcutaneous · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-8816-1 | 63629881601 | 12 BLISTER PACK in 1 CARTON (63629-8816-1) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASSMarketed from Sep 10, 2021 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206921
- Marketing start
- Listing expires
- Identifiers
- Product ID 63629-8816_d1f6c590-1315-4499-9fcd-75ff92dcc5c4SPL ID d1f6c590-1315-4499-9fcd-75ff92dcc5c4SPL set ID 028fdf0e-2340-407b-bcd8-5a99accdddbfRxCUI 1487361, 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
N463629881601followed by a unit qualifier and the quantityPackage 63629-8816-01. 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 .
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.