Prescription drug · ANDA
Dalfampridine NDC 82249-702
Dalfampridine 10 mg/1 · Tablet, Film coated, Extended release · Oral · CivicaScript LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82249-702-60 | 82249070260 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (82249-702-60)Marketed from Jul 21, 2025 |
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)
- Dalfampridine
- Generic name (nonproprietary)
- dalfampridine
- Active ingredients
- Dalfampridine — 10 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- CivicaScript LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206765
- Marketing start
- Listing expires
- Other FDA classes
- Potassium Channel Antagonists (Mechanism)
- Identifiers
- Product ID 82249-702_c40dcc84-b839-44aa-94f2-886fb1c3d75cSPL ID c40dcc84-b839-44aa-94f2-886fb1c3d75cSPL set ID c40dcc84-b839-44aa-94f2-886fb1c3d75cRxCUI 897021UNII 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
N482249070260followed by a unit qualifier and the quantityPackage 82249-0702-60. 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)
Dalfampridine extended-release tablets are 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) ]. 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 ANDA 206765
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 |
|---|---|---|---|---|
| Dalfampridine | Dalfampridine 10 mg/1 | Tablet, Film coated, Extended releaseOral | Ascend Laboratories, LLC | 67877-444 |
| Dalfampridine | Dalfampridine 10 mg/1 | Tablet, Film coated, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-876 |