Prescription drug · ANDA
Dimethyl Fumarate NDC 33342-351
Kit · Macleods Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 33342-351-93 | 33342035193 | 1 KIT in 1 KIT (33342-351-93) * 14 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (33342-349-91) * 23 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (33342-350-92)Marketed from Jun 26, 2024 |
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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210377
- Marketing start
- Listing expires
- Identifiers
- Product ID 33342-351_ef3e9cf5-b172-4e67-b621-dc94e9e9d93fSPL ID ef3e9cf5-b172-4e67-b621-dc94e9e9d93fSPL set ID f8ada3e3-55c0-43e3-95b9-c6d11ffc42ddRxCUI 1373483, 1373491, 1373497UNII FO2303MNI2UPC 0333342349095
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
N433342035193followed by a unit qualifier and the quantityPackage 33342-0351-93. 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 .
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 is 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.
Other NDCs under ANDA 210377
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Dimethyl Fumarate | Dimethyl fumarate 120 mg/1 | Capsule, Delayed releaseOral | Macleods Pharmaceuticals Limited | 33342-349 |
| Dimethyl Fumarate | Dimethyl fumarate 240 mg/1 | Capsule, Delayed releaseOral | Macleods Pharmaceuticals Limited | 33342-350 |
| Dimethyl Fumarate | — | Kit | Macleods Pharmaceuticals Limited | 33342-579 |