NDC codes

FDA NDC Directory
Product NDC (as listed)16729-292Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16729-0292Add 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
16729-292-121672902921260 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16729-292-12)Marketed from Sep 18, 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
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 206863
Marketing start
Listing expires
Other FDA classes
Potassium Channel Antagonists (Mechanism)
Identifiers
Product ID 16729-292_40bc3607-8ee1-5a56-e063-6294a90a3b3bSPL ID 40bc3607-8ee1-5a56-e063-6294a90a3b3bSPL set ID 354a97e8-35c8-418b-91b2-9e8e066cec65RxCUI 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

N416729029212 followed by a unit qualifier and the quantity

Package 16729-0292-12. 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 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)

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