NDC codes

FDA NDC Directory
Product NDC (as listed)51407-442Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51407-0442Add 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
51407-442-145140704421414 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (51407-442-14)Marketed from Apr 20, 2021

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)
dimethyl fumarate
Generic name (nonproprietary)
dimethyl fumarate
Active ingredients
Dimethyl fumarate — 120 mg/1
Dosage form
Capsule, Delayed release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210382
Marketing start
Listing expires
Identifiers
Product ID 51407-442_4f87b078-e3ab-cc4b-e063-6294a90a88ccSPL ID 4f87b078-e3ab-cc4b-e063-6294a90a88ccSPL set ID b8e5184d-5d1d-0a89-e053-2995a90a2d6dRxCUI 1373483, 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

N451407044214 followed by a unit qualifier and the quantity

Package 51407-0442-14. 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.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210382

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

FDA NDC Directory listings under ANDA 210382
ProductStrengthForm · routeLabelerProduct NDC
dimethyl fumarateDimethyl fumarate 120 mg/1Capsule, Delayed releaseOralUpsher-Smith Laboratories, LLC24979-127
dimethyl fumarateDimethyl fumarate 240 mg/1Capsule, Delayed releaseOralUpsher-Smith Laboratories, LLC24979-128
dimethyl fumarateDimethyl fumarate 240 mg/1Capsule, Delayed releaseOralGolden State Medical Supply, Inc.51407-441

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dimethyl fumarate NDC 51407-442 | Med-Code