Dimethyl Fumarate NDC 31722-658

NDC codes

FDA NDC Directory

Product NDC (as listed)31722-658Labeler and product segments. Claims need a package NDC.

Product NDC at billing width31722-0658Add 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
31722-658-31	31722065831	1 BOTTLE in 1 CARTON (31722-658-31) / 46 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Sep 24, 2020
31722-658-32	31722065832	1 BOTTLE in 1 CARTON (31722-658-32) / 60 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Sep 24, 2020
31722-658-33	31722065833	10 BLISTER PACK in 1 CARTON (31722-658-33) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACKMarketed from Sep 24, 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 — 240 mg/1
Dosage form: Capsule, Delayed release
Route: Oral
Labeler: Camber Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210500
Marketing start: Sep 24, 2020
Listing expires: Dec 31, 2026
Identifiers: Product ID 31722-658_1814ba82-76cc-c580-e063-6294a90a5e57SPL ID 1814ba82-76cc-c580-e063-6294a90a5e57SPL set ID b856ac70-71cd-477b-95b1-0a6132c260e8RxCUI 1373483, 1373491, 1373497UNII FO2303MNI2UPC 0331722657310, 0331722658324, 0331722658317

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

N431722065831 followed by a unit qualifier and the quantity

Package 31722-0658-31. 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 10, 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 210500

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

FDA NDC Directory listings under ANDA 210500
Product	Strength	Form · route	Labeler	Product NDC
Dimethyl Fumarate	Dimethyl fumarate 240 mg/1	Capsule, Delayed releaseOral	Quallent Pharmaceuticals Health LLC	82009-138
Dimethyl Fumarate	Dimethyl fumarate 120 mg/1	Capsule, Delayed releaseOral	Camber Pharmaceuticals, Inc.	31722-657
Dimethyl Fumarate	—	Kit	Camber Pharmaceuticals, Inc.	31722-680
Dimethyl Fumarate	Dimethyl fumarate 240 mg/1	Capsule, Delayed releaseOral	A-S Medication Solutions	50090-5288