Prescription drug · NDA
Xadago (Safinamide mesylate) NDC 27505-110
Safinamide mesylate 50 mg/1 · Tablet, Film coated · Oral · MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 27505-110-14 | 27505011014 | 1 BLISTER PACK in 1 CARTON (27505-110-14) / 14 TABLET, FILM COATED in 1 BLISTER PACKMarketed from May 8, 2017 | |
| 27505-110-30 | 27505011030 | 1 BOTTLE in 1 CARTON (27505-110-30) / 30 TABLET, FILM COATED in 1 BOTTLEMarketed from May 8, 2017 | |
| 27505-110-90 | 27505011090 | 1 BOTTLE in 1 CARTON (27505-110-90) / 90 TABLET, FILM COATED in 1 BOTTLEMarketed from May 8, 2017 |
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)
- Xadago
- Generic name (nonproprietary)
- safinamide mesylate
- Active ingredients
- Safinamide mesylate — 50 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc.NDC labeler code 27505
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 207145
- Marketing start
- Listing expires
- Other FDA classes
- Breast Cancer Resistance Protein Inhibitors (Mechanism)Monoamine Oxidase-B Inhibitors (Mechanism)
- Identifiers
- Product ID 27505-110_5bafa407-4ae6-2d85-e063-6394a90aba71SPL ID 5bafa407-4ae6-2d85-e063-6394a90aba71
- Pharmacologic class
- Monoamine Oxidase Type B Inhibitor
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N427505011014followed by a unit qualifier and the quantityPackage 27505-0110-14. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 27505-110
- What is NDC 27505-110?
- 27505-110 is the product NDC for Xadago (safinamide mesylate), Safinamide mesylate 50 mg/1 tablet, film coated, listed with the FDA by MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Xadago (Safinamide mesylate).
- What is the active ingredient?
- Safinamide mesylate.
- Who is the labeler?
- MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc., NDC labeler code 27505. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Xadago?
- 1 other product NDC are listed under this name. See all Xadago NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Xadago products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Xadagosafinamide mesylate | Safinamide mesylate 100 mg/1 | Tablet, Film coatedOral | MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc. | 27505-111 | 27505-0111-1427505-0111-3027505-0111-90 |
Other NDCs under NDA 207145
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 |
|---|---|---|---|---|
| Xadagosafinamide mesylate | Safinamide mesylate 100 mg/1 | Tablet, Film coatedOral | MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc. | 27505-111 |