Dimethyl Fumarate NDC 69238-1318

NDC codes

FDA NDC Directory

Product NDC (as listed)69238-1318Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69238-1318Add 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	Copy
69238-1318-4	69238131804	1 BOTTLE in 1 CARTON (69238-1318-4) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Sep 28, 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 — 120 mg/1
Dosage form: Capsule, Delayed release
Route: Oral
Labeler: Amneal Pharmaceuticals NY LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210402
Marketing start: Sep 28, 2020
Listing expires: Dec 31, 2026
Identifiers: Product ID 69238-1318_76c5e6b0-c799-45cf-adb6-2d3845639b62SPL ID 76c5e6b0-c799-45cf-adb6-2d3845639b62SPL set ID 4c7626c6-2b1b-4865-818c-0c79c18c049dRxCUI 1373483, 1373491, 1373497UNII FO2303MNI2UPC 0369238131963, 0369238162639, 0369238162684

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

N469238131804 followed by a unit qualifier and the quantity

Package 69238-1318-04. 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 May 30, 2025.

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 210402

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

FDA NDC Directory listings under ANDA 210402
Product	Strength	Form · route	Labeler	Product NDC
Dimethyl Fumarate	Dimethyl fumarate 240 mg/1	Capsule, Delayed releaseOral	Amneal Pharmaceuticals NY LLC	69238-1319
Dimethyl Fumarate	—	Kit	Amneal Pharmaceuticals NY LLC	69238-1626