Prescription drug · NDA
Tecfidera (Dimethyl fumarate) NDC 64406-005
Dimethyl fumarate 120 mg/1 · Capsule · Oral · Biogen Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64406-005-01 | 6440600050164406000501 | 1 BOTTLE, PLASTIC in 1 CARTON (64406-005-01) / 14 CAPSULE in 1 BOTTLE, PLASTICMarketed from Mar 27, 2013 |
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)
- Tecfidera
- Generic name (nonproprietary)
- dimethyl fumarate
- Active ingredients
- Dimethyl fumarate — 120 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Biogen Inc.NDC labeler code 64406
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 204063
- Marketing start
- Listing expires
- Identifiers
- Product ID 64406-005_521e4305-9450-42a4-881b-05946acaa8faSPL ID 521e4305-9450-42a4-881b-05946acaa8faSPL set ID 665d7e74-036c-5f68-5b67-ab84b9b49151RxCUI 1373483, 1373489, 1373491, 1373493, 1373497, 1373498UNII FO2303MNI2UPC 0364406005015, 0364406005107, 0364406005084
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
N464406000501followed by a unit qualifier and the quantityPackage 64406-0005-01. 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)
TECFIDERA 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. TECFIDERA 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 64406-005
- What is NDC 64406-005?
- 64406-005 is the product NDC for Tecfidera (dimethyl fumarate), Dimethyl fumarate 120 mg/1 capsule, listed with the FDA by Biogen Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tecfidera (Dimethyl fumarate).
- What is the active ingredient?
- Dimethyl fumarate.
- Who is the labeler?
- Biogen Inc., NDC labeler code 64406. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tecfidera?
- 2 other product NDCs are listed under this name. See all Tecfidera NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tecfidera products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tecfideradimethyl fumarate | Dimethyl fumarate 240 mg/1 | CapsuleOral | Biogen Inc. | 64406-006 | 64406-0006-02 |
| Tecfideradimethyl fumarate | — | Kit | Biogen Inc. | 64406-007 | 64406-0007-03 |
Other NDCs under NDA 204063
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 |
|---|---|---|---|---|
| Tecfideradimethyl fumarate | Dimethyl fumarate 240 mg/1 | CapsuleOral | Biogen Inc. | 64406-006 |
| Tecfideradimethyl fumarate | — | Kit | Biogen Inc. | 64406-007 |