Dalfampridine NDC 0591-2533

NDC codes

FDA NDC Directory

Product NDC (as listed)0591-2533Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00591-2533Add 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	Copy
0591-2533-60	00591253360	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0591-2533-60)Marketed from May 31, 2022

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): Dalfampridine
Generic name (nonproprietary): dalfampridine
Active ingredients: Dalfampridine — 10 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Actavis Pharma, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206836
Marketing start: May 31, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Potassium Channel Antagonists (Mechanism)
Identifiers: Product ID 0591-2533_f2d33c82-a69f-4f6a-bd74-2c91efd6cab8SPL ID f2d33c82-a69f-4f6a-bd74-2c91efd6cab8SPL set ID ed826777-b8c4-4d35-aa64-a4c28452baa8RxCUI 897021UNII BH3B64OKL9UPC 0305912533609
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

N400591253360 followed by a unit qualifier and the quantity

Package 00591-2533-60. 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 Dec 2, 2021.

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.

Full label on DailyMed (opens in a new tab)