Prescription drug · NDA
Ampyra (dalfampridine) NDC 10144-427
Dalfampridine 10 mg/1 · Tablet, Film coated, Extended release · Oral · Merz Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10144-427-60 | 10144042760 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10144-427-60)Marketed from Mar 1, 2010 |
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)
- Ampyra
- Generic name (nonproprietary)
- dalfampridine
- Active ingredients
- Dalfampridine — 10 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Merz Pharmaceuticals, LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022250
- Marketing start
- Listing expires
- Other FDA classes
- Potassium Channel Antagonists (Mechanism)
- Identifiers
- Product ID 10144-427_dda9045d-2f23-412c-9543-74832f421739SPL ID dda9045d-2f23-412c-9543-74832f421739SPL set ID 550eb76a-e4a6-4fa1-ad65-c0fd8b0ce783RxCUI 897021, 897025UNII BH3B64OKL9UPC 0310144427602
- Pharmacologic class
- Potassium Channel Blocker
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
N410144042760followed by a unit qualifier and the quantityPackage 10144-0427-60. 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)
AMPYRA is indicated as a treatment to improve walking in adult patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed [see Clinical Studies (14) ]. AMPYRA ® (dalfampridine) is a potassium channel blocker indicated to improve walking in adult patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed ( 1 , 14 ).
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 022250
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 |
|---|---|---|---|---|
| Ampyradalfampridine | Dalfampridine 10 mg/1 | Tablet, Film coated, Extended releaseOral | Merz Pharmaceuticals, LLC | 0259-5010 |