Dalfampridine NDC 65862-863

NDC codes

FDA NDC Directory

Product NDC (as listed)65862-863Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65862-0863Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
65862-863-01	65862086301	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-863-01)Marketed from Jun 25, 2018
65862-863-05	65862086305	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-863-05)Marketed from Jun 25, 2018
65862-863-60	65862086360	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-863-60)Marketed from Jun 25, 2018

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: Aurobindo Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206811
Marketing start: Jun 25, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Potassium Channel Antagonists (Mechanism)
Identifiers: Product ID 65862-863_8a071f78-8849-495d-ad29-832d5f250a19SPL ID 8a071f78-8849-495d-ad29-832d5f250a19SPL set ID 43996322-7d83-4420-9e61-4ed37f710feeRxCUI 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

N465862086301 followed by a unit qualifier and the quantity

Package 65862-0863-01. 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 Feb 15, 2024.

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 extended-release tablets are 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.

Full label on DailyMed (opens in a new tab)