Dimethyl Fumarate (dimethyl-fumarate) NDC 68462-307

NDC codes

FDA NDC Directory

Product NDC (as listed)68462-307Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68462-0307Add 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
68462-307-05	68462030705	500 CAPSULE in 1 BOTTLE (68462-307-05)Marketed from Oct 6, 2020
68462-307-41	68462030741	14 CAPSULE in 1 BOTTLE (68462-307-41)Marketed from Oct 6, 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
Route: Oral
Labeler: Glenmark Pharmaceuticals Inc., USA
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210309
Marketing start: Oct 6, 2020
Listing expires: Dec 31, 2026
Identifiers: Product ID 68462-307_74611591-657b-40e8-8ae1-1e5533a05d97SPL ID 74611591-657b-40e8-8ae1-1e5533a05d97SPL set ID c3f65da9-f5f4-4161-aded-c23b16fd49edRxCUI 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

N468462030705 followed by a unit qualifier and the quantity

Package 68462-0307-05. 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 23, 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 210309

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

FDA NDC Directory listings under ANDA 210309
Product	Strength	Form · route	Labeler	Product NDC
Dimethyl Fumaratedimethyl fumarate kit	—	Kit	Glenmark Pharmaceuticals Inc., USA	68462-570
Dimethyl Fumaratedimethyl-fumarate	Dimethyl fumarate 240 mg/1	CapsuleOral	Glenmark Pharmaceuticals Inc., USA	68462-308