NDC codes

FDA NDC Directory
Product NDC (as listed)67877-444Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67877-0444Add 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
67877-444-056787704440567877044405500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-444-05)Marketed from Jul 31, 2018
67877-444-60678770444606787704446060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-444-60)Marketed from Jul 31, 2018
67877-444-90678770444906787704449090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-444-90)Marketed from Jul 31, 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
Ascend Laboratories, LLCNDC labeler code 67877
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 206765
Marketing start
Listing expires
Other FDA classes
Potassium Channel Antagonists (Mechanism)
Identifiers
Product ID 67877-444_7359109d-e6d1-4e42-bb3b-746e8d5fb686SPL ID 7359109d-e6d1-4e42-bb3b-746e8d5fb686SPL set ID e10b2d92-2824-4395-8883-6fd52c784aa4RxCUI 897021UNII BH3B64OKL9UPC 0367877444604
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

N467877044405 followed by a unit qualifier and the quantity

Package 67877-0444-05. 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 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 67877-444

What is NDC 67877-444?
67877-444 is the product NDC for Dalfampridine, Dalfampridine 10 mg/1 tablet, film coated, extended release, listed with the FDA by Ascend Laboratories, LLC. 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?
Ascend Laboratories, LLC, NDC labeler code 67877. 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 releaseOralSun Pharmaceutical Industries, Inc.62756-42962756-0429-86
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 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

Other NDCs under ANDA 206765

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 206765
ProductStrengthForm · routeLabelerProduct NDC
DalfampridineDalfampridine 10 mg/1Tablet, Film coated, Extended releaseOralGolden State Medical Supply, Inc.51407-876
DalfampridineDalfampridine 10 mg/1Tablet, Film coated, Extended releaseOralCivicaScript LLC82249-702

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