What is NDC 65862-863?

65862-863 is the product NDC for Dalfampridine, Dalfampridine 10 mg/1 tablet, film coated, extended release, listed with the FDA by Aurobindo Pharma Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.

Aurobindo Pharma Limited, NDC labeler code 65862. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Dalfampridine NDC 65862-863 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)65862-863Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65862-0863Add 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
65862-863-01	6586208630165862086301	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-863-01)Marketed from Jun 25, 2018
65862-863-05	6586208630565862086305	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-863-05)Marketed from Jun 25, 2018
65862-863-60	6586208636065862086360	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-863-60)Marketed from Jun 25, 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: Aurobindo Pharma LimitedNDC labeler code 65862
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206811
Marketing start: Jun 25, 2018
Listing expires: Dec 31, 2027
Other FDA classes: Potassium Channel Antagonists (Mechanism)
Identifiers: Product ID 65862-863_8a071f78-8849-495d-ad29-832d5f250a19SPL ID 8a071f78-8849-495d-ad29-832d5f250a19SPL set ID 43996322-7d83-4420-9e61-4ed37f710feeRxCUI 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

N465862086301 followed by a unit qualifier and the quantity

Package 65862-0863-01. 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 Feb 15, 2024.

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)

About NDC 65862-863

What is NDC 65862-863?: 65862-863 is the product NDC for Dalfampridine, Dalfampridine 10 mg/1 tablet, film coated, extended release, listed with the FDA by Aurobindo Pharma 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?: Aurobindo Pharma Limited, NDC labeler code 65862. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Dalfampridine NDCs
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	Micro Labs Limited	42571-275	42571-0275-0542571-0275-1042571-0275-60
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