Prescription drug · ANDA
Dimethyl Fumarate NDC 33342-349
Dimethyl fumarate 120 mg/1 · Capsule, Delayed release · Oral · Macleods Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 33342-349-09 | 3334203490933342034909 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-349-09)Marketed from Jun 26, 2024 | |
| 33342-349-94 | 3334203499433342034994 | 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-349-94)Marketed from Jun 27, 2025 | |
| 33342-349-97 | 3334203499733342034997 | 1 BLISTER PACK in 1 CARTON (33342-349-97) / 14 CAPSULE, DELAYED RELEASE in 1 BLISTER PACKMarketed 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
- Active ingredients
- Dimethyl fumarate — 120 mg/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- Labeler
- Macleods Pharmaceuticals LimitedNDC labeler code 33342
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210377
- Marketing start
- Listing expires
- Identifiers
- Product ID 33342-349_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 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
N433342034909followed by a unit qualifier and the quantityPackage 33342-0349-09. 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.
About NDC 33342-349
- What is NDC 33342-349?
- 33342-349 is the product NDC for Dimethyl Fumarate, Dimethyl fumarate 120 mg/1 capsule, delayed release, listed with the FDA by Macleods Pharmaceuticals Limited. It has 3 package NDCs, 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?
- Macleods Pharmaceuticals Limited, NDC labeler code 33342. 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.
Related NDCs: other Dimethyl Fumarate products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 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 |
| Dimethyl Fumarate | Dimethyl fumarate 240 mg/1 | Capsule, Delayed releaseOral | Aurobindo Pharma Limited | 59651-084 | 59651-0084-60 |
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 240 mg/1 | Capsule, Delayed releaseOral | Macleods Pharmaceuticals Limited | 33342-350 |
| Dimethyl Fumarate | — | Kit | Macleods Pharmaceuticals Limited | 33342-351 |
| Dimethyl Fumarate | — | Kit | Macleods Pharmaceuticals Limited | 33342-579 |