Dimethyl Fumarate NDC 43547-025

NDC codes

FDA NDC Directory

Product NDC (as listed)43547-025Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43547-0025Add 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
43547-025-06	43547002506	60 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43547-025-06)Marketed from Oct 18, 2022
43547-025-46	43547002546	46 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43547-025-46)Marketed from Oct 18, 2022

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 — 240 mg/1
Dosage form: Capsule, Delayed release
Route: Oral
Labeler: Solco Healthcare US, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210414
Marketing start: Oct 18, 2022
Listing expires: Dec 31, 2026
Identifiers: Product ID 43547-025_870120b7-7d68-4e5f-98cc-ac646624feb4SPL ID 870120b7-7d68-4e5f-98cc-ac646624feb4SPL set ID a3677dce-a44b-481f-8a76-9ff3a4d42105RxCUI 1373483, 1373491UNII FO2303MNI2UPC 0343547025069, 0343547024147

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

N443547002506 followed by a unit qualifier and the quantity

Package 43547-0025-06. 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 Jun 27, 2024.

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 210414

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

FDA NDC Directory listings under ANDA 210414
Product	Strength	Form · route	Labeler	Product NDC
Dimethyl Fumarate	Dimethyl fumarate 120 mg/1	Capsule, Delayed releaseOral	Solco Healthcare US, LLC	43547-024