What is NDC 69097-322?

69097-322 is the product NDC for Dimethyl Fumarate, Dimethyl fumarate 120 mg/1 capsule, delayed release, listed with the FDA by Cipla USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Cipla USA Inc., NDC labeler code 69097. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Dimethyl Fumarate?

45 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Dimethyl Fumarate NDC 69097-322 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69097-322Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69097-0322Add 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
69097-322-89	6909703228969097032289	1 BOTTLE, PLASTIC in 1 CARTON (69097-322-89) / 14 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
Active ingredients: Dimethyl fumarate — 120 mg/1
Dosage form: Capsule, Delayed release
Route: Oral
Labeler: Cipla USA Inc.NDC labeler code 69097
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210305
Marketing start: Sep 24, 2020
Listing expires: Dec 31, 2027
Identifiers: Product ID 69097-322_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 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

N469097032289 followed by a unit qualifier and the quantity

Package 69097-0322-89. 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)

About NDC 69097-322

What is NDC 69097-322?: 69097-322 is the product NDC for Dimethyl Fumarate, Dimethyl fumarate 120 mg/1 capsule, delayed release, listed with the FDA by Cipla USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Dimethyl Fumarate.
What is the active ingredient?: Dimethyl fumarate.
Who is the labeler?: Cipla USA Inc., NDC labeler code 69097. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Dimethyl Fumarate?: 45 other product NDCs are listed under this name. See all Dimethyl Fumarate NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Dimethyl Fumarate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Dimethyl Fumarate	—	Kit	Macleods Pharmaceuticals Limited	33342-579	33342-0579-96
Dimethyl fumarate	Dimethyl fumarate 120 mg/1	Capsule, Delayed releaseOral	CivicaScript LLC	82249-745	82249-0745-14
Dimethyl fumarate	Dimethyl fumarate 240 mg/1	Capsule, Delayed releaseOral	CivicaScript LLC	82249-747	82249-0747-60
Dimethyl Fumarate	Dimethyl fumarate 120 mg/1	Capsule, Delayed releaseOral	Macleods Pharmaceuticals Limited	33342-349	33342-0349-0933342-0349-9433342-0349-97
Dimethyl Fumarate	Dimethyl fumarate 240 mg/1	Capsule, Delayed releaseOral	Macleods Pharmaceuticals Limited	33342-350	33342-0350-0933342-0350-95
Dimethyl Fumarate	—	Kit	Macleods Pharmaceuticals Limited	33342-351	33342-0351-93
Dimethyl Fumarate	Dimethyl fumarate 240 mg/1	Capsule, Delayed releaseOral	Quallent Pharmaceuticals Health LLC	82009-138	82009-0138-60
Dimethyl Fumarate	Dimethyl fumarate 120 mg/1	Capsule, Delayed releaseOral	SOLA Pharmaceuticals, LLC	70512-852	70512-0852-14
Dimethyl Fumarate	Dimethyl fumarate 240 mg/1	Capsule, Delayed releaseOral	SOLA Pharmaceuticals, LLC	70512-853	70512-0853-60
Dimethyl Fumarate	Dimethyl fumarate 120 mg/1	Capsule, Delayed releaseOral	Aurobindo Pharma Limited	59651-083	59651-0083-14

All 46 Dimethyl Fumarate NDCs

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	—	Kit	Cipla USA Inc.	69097-552