dimethyl fumarate NDC 70771-1531

NDC codes

FDA NDC Directory

Product NDC (as listed)70771-1531Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70771-1531Add 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
70771-1531-6	70771153106	60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70771-1531-6)Marketed from Sep 28, 2020 · Sample package
70771-1531-8	70771153108	46 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70771-1531-8)Marketed from Sep 28, 2020 · Sample package

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
Labeler: Zydus Lifesciences Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210538
Marketing start: Sep 28, 2020
Listing expires: Dec 31, 2026
Identifiers: Product ID 70771-1531_d8dceb92-b903-4b29-b3e6-4651fbc598feSPL ID d8dceb92-b903-4b29-b3e6-4651fbc598feSPL set ID 7203a262-de0f-42dd-b4fb-8856758b82e9RxCUI 1373483, 1373491, 1373497UNII 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

N470771153106 followed by a unit qualifier and the quantity

Package 70771-1531-06. 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 Apr 1, 2025.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210538

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

FDA NDC Directory listings under ANDA 210538
Product	Strength	Form · route	Labeler	Product NDC
dimethyl fumarate	Dimethyl fumarate 120 mg/1	Capsule, Delayed releaseOral	Zydus Lifesciences Limited	70771-1530
dimethyl fumarate	Dimethyl fumarate 120 mg/1	Capsule, Delayed releaseOral	Zydus Pharmaceuticals USA Inc.	70710-1204
dimethyl fumarate	Dimethyl fumarate 240 mg/1	Capsule, Delayed releaseOral	Zydus Pharmaceuticals USA Inc.	70710-1205