Dimethyl Fumarate NDC 69097-552

NDC codes

FDA NDC Directory

Product NDC (as listed)69097-552Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69097-0552Add 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
69097-552-03	69097055203	1 KIT in 1 KIT (69097-552-03) * 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC * 46 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTICMarketed 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
Dosage form: Kit
Labeler: Cipla USA Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210305
Marketing start: Sep 24, 2020
Listing expires: Dec 31, 2026
Identifiers: Product ID 69097-552_d64e8be8-de52-40c2-8730-bef67c6b0914SPL ID d64e8be8-de52-40c2-8730-bef67c6b0914SPL set ID 6c42107a-2a42-4263-97b6-ae0d7675c92aRxCUI 1373483, 1373491, 1373497UNII FO2303MNI2UPC 0369097323035, 0369097322892, 0369097323882, 0369097552039

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N469097055203 followed by a unit qualifier and the quantity

Package 69097-0552-03. 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 Mar 22, 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 210305

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

FDA NDC Directory listings under ANDA 210305
Product	Strength	Form · route	Labeler	Product NDC
Dimethyl Fumarate	Dimethyl fumarate 240 mg/1	Capsule, Delayed releaseOral	Cipla USA Inc.	69097-323
Dimethyl Fumarate	Dimethyl fumarate 120 mg/1	Capsule, Delayed releaseOral	Cipla USA Inc.	69097-322