NDC codes

FDA NDC Directory
Product NDC (as listed)10144-427Labeler and product segments. Claims need a package NDC.
Product NDC at billing width10144-0427Add 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 NDC11-digit (billing)PackageCopy
10144-427-601014404276060 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
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

N410144042760 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 022250

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 022250
ProductStrengthForm · routeLabelerProduct NDC
AmpyradalfampridineDalfampridine 10 mg/1Tablet, Film coated, Extended releaseOralMerz Pharmaceuticals, LLC0259-5010

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