Dimethyl Fumarate NDC 16729-417

NDC codes

FDA NDC Directory

Product NDC (as listed)16729-417Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16729-0417Add 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
16729-417-12	16729041712	60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16729-417-12)Marketed from Jan 13, 2021
16729-417-59	16729041759	180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16729-417-59)Marketed from Jan 20, 2021

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: Accord Healthcare Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210499
Marketing start: Jan 13, 2021
Listing expires: Dec 31, 2027
Identifiers: Product ID 16729-417_5bb2bc09-0013-117d-e063-6294a90a24e4SPL ID 5bb2bc09-0013-117d-e063-6294a90a24e4

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

N416729041712 followed by a unit qualifier and the quantity

Package 16729-0417-12. 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

The FDA listing for this product does not reference a label (SPL) set.

Other NDCs under ANDA 210499

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

FDA NDC Directory listings under ANDA 210499
Product	Strength	Form · route	Labeler	Product NDC
Dimethyl Fumarate	Dimethyl fumarate 120 mg/1	Capsule, Delayed releaseOral	Accord Healthcare Inc.	16729-416