NDC codes

FDA NDC Directory
Product NDC (as listed)62756-429Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62756-0429Add 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
62756-429-86627560429866275604298660 TABLET, EXTENDED RELEASE in 1 BOTTLE (62756-429-86)Marketed from May 22, 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
Sun Pharmaceutical Industries, Inc.NDC labeler code 62756
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 208292
Marketing start
Listing expires
Other FDA classes
Potassium Channel Antagonists (Mechanism)
Identifiers
Product ID 62756-429_c3c3b8ae-9dac-40fc-8569-b26d6befbf01SPL ID c3c3b8ae-9dac-40fc-8569-b26d6befbf01SPL set ID d61e15fa-0334-49a0-ab41-c9a36b726b57RxCUI 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

N462756042986 followed by a unit qualifier and the quantity

Package 62756-0429-86. 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 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)

About NDC 62756-429

What is NDC 62756-429?
62756-429 is the product NDC for Dalfampridine, Dalfampridine 10 mg/1 tablet, extended release, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 1 package NDC, 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?
Sun Pharmaceutical Industries, Inc., NDC labeler code 62756. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
DalfampridineDalfampridine 10 mg/1Tablet, Film coated, Extended releaseOralCivicaScript LLC82249-70282249-0702-60
DalfampridineDalfampridine 10 mg/1Tablet, Film coated, Extended releaseOralActavis Pharma, Inc.0591-253300591-2533-60
DalfampridineDalfampridine 10 mg/1Tablet, Extended releaseOralMicro Labs Limited42571-27542571-0275-0542571-0275-1042571-0275-60
DalfampridineDalfampridine 10 mg/1Tablet, Extended releaseOralBryant Ranch Prepack72162-245972162-2459-06
DalfampridineDalfampridine 10 mg/1Tablet, Film coated, Extended releaseOralAccord Healthcare Inc.16729-29216729-0292-12
DalfampridineDalfampridine 10 mg/1Tablet, Film coated, Extended releaseOralAscend Laboratories, LLC67877-44467877-0444-0567877-0444-6067877-0444-90
DalfampridineDalfampridine 10 mg/1Tablet, Film coated, Extended releaseOralGolden State Medical Supply, Inc.51407-87651407-0876-60
DalfampridineDalfampridine 10 mg/1Tablet, Film coated, Extended releaseOralAurobindo Pharma Limited65862-86365862-0863-0165862-0863-0565862-0863-60

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