Prescription drug · ANDA
Dalfampridine NDC 42571-275
Dalfampridine 10 mg/1 · Tablet, Extended release · Oral · Micro Labs Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42571-275-05 | 4257102750542571027505 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42571-275-05)Marketed from Mar 21, 2019 | |
| 42571-275-10 | 4257102751042571027510 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (42571-275-10)Marketed from Mar 21, 2019 | |
| 42571-275-60 | 4257102756042571027560 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (42571-275-60)Marketed from Mar 21, 2019 |
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, Extended release
- Route
- Oral
- Labeler
- Micro Labs LimitedNDC labeler code 42571
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210158
- Marketing start
- Listing expires
- Other FDA classes
- Potassium Channel Antagonists (Mechanism)
- Identifiers
- Product ID 42571-275_3afc3c42-1157-b612-e063-6294a90ac179SPL ID 3afc3c42-1157-b612-e063-6294a90ac179SPL set ID 302c8270-4711-4ca4-bee8-be0738fbe094RxCUI 897021UNII BH3B64OKL9UPC 0342571275600
- 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
N442571027505followed by a unit qualifier and the quantityPackage 42571-0275-05. 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 tablet 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) ]. Dalfampridine extended-release tablet 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.
About NDC 42571-275
- What is NDC 42571-275?
- 42571-275 is the product NDC for Dalfampridine, Dalfampridine 10 mg/1 tablet, extended release, listed with the FDA by Micro Labs Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dalfampridine.
- What is the active ingredient?
- Dalfampridine.
- Who is the labeler?
- Micro Labs Limited, NDC labeler code 42571. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dalfampridine?
- 8 other product NDCs are listed under this name. See all Dalfampridine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Dalfampridine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Dalfampridine | Dalfampridine 10 mg/1 | Tablet, Film coated, Extended releaseOral | CivicaScript LLC | 82249-702 | 82249-0702-60 |
| Dalfampridine | Dalfampridine 10 mg/1 | Tablet, Film coated, Extended releaseOral | Actavis Pharma, Inc. | 0591-2533 | 00591-2533-60 |
| Dalfampridine | Dalfampridine 10 mg/1 | Tablet, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 62756-429 | 62756-0429-86 |
| Dalfampridine | Dalfampridine 10 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 72162-2459 | 72162-2459-06 |
| Dalfampridine | Dalfampridine 10 mg/1 | Tablet, Film coated, Extended releaseOral | Accord Healthcare Inc. | 16729-292 | 16729-0292-12 |
| Dalfampridine | Dalfampridine 10 mg/1 | Tablet, Film coated, Extended releaseOral | Ascend Laboratories, LLC | 67877-444 | 67877-0444-0567877-0444-6067877-0444-90 |
| Dalfampridine | Dalfampridine 10 mg/1 | Tablet, Film coated, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-876 | 51407-0876-60 |
| Dalfampridine | Dalfampridine 10 mg/1 | Tablet, Film coated, Extended releaseOral | Aurobindo Pharma Limited | 65862-863 | 65862-0863-0165862-0863-0565862-0863-60 |
Other NDCs under ANDA 210158
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Dalfampridine | Dalfampridine 10 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 72162-2459 |