NDC codes

FDA NDC Directory
Product NDC (as listed)50090-5288Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-5288Add 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
50090-5288-0500905288001 CAPSULE, DELAYED RELEASE in 1 KIT (50090-5288-0)Marketed from Oct 23, 2020

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Dimethyl Fumarate
Generic name (nonproprietary)
dimethyl fumarate
Active ingredients
Dimethyl fumarate — 240 mg/1
Dosage form
Capsule, Delayed release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210500
Marketing start
Listing expires
Identifiers
Product ID 50090-5288_43b9bf3a-1ec7-4ca5-9931-61528baadc39SPL ID 43b9bf3a-1ec7-4ca5-9931-61528baadc39SPL set ID c2b19329-5c1d-4879-85a9-36ffec3ff5cbRxCUI 1373491UNII FO2303MNI2

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

N450090528800 followed by a unit qualifier and the quantity

Package 50090-5288-00. 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)

Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210500

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

FDA NDC Directory listings under ANDA 210500
ProductStrengthForm · routeLabelerProduct NDC
Dimethyl FumarateDimethyl fumarate 240 mg/1Capsule, Delayed releaseOralQuallent Pharmaceuticals Health LLC82009-138
Dimethyl FumarateDimethyl fumarate 240 mg/1Capsule, Delayed releaseOralCamber Pharmaceuticals, Inc.31722-658
Dimethyl FumarateDimethyl fumarate 120 mg/1Capsule, Delayed releaseOralCamber Pharmaceuticals, Inc.31722-657
Dimethyl Fumarate—KitCamber Pharmaceuticals, Inc.31722-680

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