Prescription drug · NDA
Ampyra (Dalfampridine) NDC 0259-5010
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 |
|---|---|---|---|
| 0259-5010-60 | 0025950106000259501060 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0259-5010-60)Marketed from Mar 1, 2010 |
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)
- Ampyra
- Generic name (nonproprietary)
- dalfampridine
- Active ingredients
- Dalfampridine — 10 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Merz Pharmaceuticals, LLCNDC labeler code 0259
- 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 0259-5010_b0f65c2b-ee14-421f-9f24-178e108e38cfSPL ID b0f65c2b-ee14-421f-9f24-178e108e38cfSPL set ID 974fb2af-7012-4989-b330-e44a31c9c3e5RxCUI 897021, 897025UNII BH3B64OKL9
- 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
N400259501060followed by a unit qualifier and the quantityPackage 00259-5010-60. 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.
About NDC 0259-5010
- What is NDC 0259-5010?
- 0259-5010 is the product NDC for Ampyra (dalfampridine), Dalfampridine 10 mg/1 tablet, film coated, extended release, listed with the FDA by Merz Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ampyra (Dalfampridine).
- What is the active ingredient?
- Dalfampridine.
- Who is the labeler?
- Merz Pharmaceuticals, LLC, NDC labeler code 0259. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ampyra?
- 1 other product NDC are listed under this name. See all Ampyra NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ampyra products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ampyradalfampridine | Dalfampridine 10 mg/1 | Tablet, Film coated, Extended releaseOral | Merz Pharmaceuticals, LLC | 10144-427 | 10144-0427-60 |
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 | 10144-427 |