Dimethyl Fumarate NDC 43598-429

NDC codes

FDA NDC Directory

Product NDC (as listed)43598-429Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43598-0429Add 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
43598-429-52	43598042952	1 BOTTLE in 1 CARTON (43598-429-52) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Sep 25, 2020

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
Labeler: Dr. Reddy's Laboratories Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210460
Marketing start: Sep 25, 2020
Listing expires: Dec 31, 2026
Identifiers: Product ID 43598-429_fcfea8cf-7720-664c-345c-b8baeff438eeSPL ID fcfea8cf-7720-664c-345c-b8baeff438eeSPL set ID b00dcf89-59d3-9ab2-fd9b-16b9ec2d677bRxCUI 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

N443598042952 followed by a unit qualifier and the quantity

Package 43598-0429-52. 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 Oct 10, 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 is 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 210460

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

FDA NDC Directory listings under ANDA 210460
Product	Strength	Form · route	Labeler	Product NDC
Dimethyl Fumarate	Dimethyl fumarate 120 mg/1	Capsule, Delayed releaseOral	MSN LABORATORIES PRIVATE LIMITED	69539-042
Dimethyl Fumarate	Dimethyl fumarate 240 mg/1	Capsule, Delayed releaseOral	MSN LABORATORIES PRIVATE LIMITED	69539-043
Dimethyl Fumarate	—	Kit	MSN LABORATORIES PRIVATE LIMITED	69539-240
Dimethyl Fumarate	Dimethyl fumarate 240 mg/1	Capsule, Delayed releaseOral	Dr. Reddy's Laboratories Inc.	43598-430