Prescription drug · ANDA
Dalfampridine NDC 16729-292
Dalfampridine 10 mg/1 · Tablet, Film coated, Extended release · Oral · Accord Healthcare Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16729-292-12 | 16729029212 | 60 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
- Labeler
- Accord Healthcare Inc.
- 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
N416729029212followed by a unit qualifier and the quantityPackage 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.