Prescription drug · ANDA
dimethyl fumarate NDC 70710-1204
Dimethyl fumarate 120 mg/1 · Capsule, Delayed release · Oral · Zydus Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70710-1204-7 | 70710120407 | 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70710-1204-7)Marketed from Sep 28, 2020 · Sample package |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210538
- Marketing start
- Listing expires
- Identifiers
- Product ID 70710-1204_548169c7-23fb-46e1-9a8d-556a00ee5cbcSPL ID 548169c7-23fb-46e1-9a8d-556a00ee5cbcSPL set ID e7ef9b9e-d97a-4a56-b792-a1a255613156RxCUI 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
N470710120407followed by a unit qualifier and the quantityPackage 70710-1204-07. 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 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. Dimethyl fumarate 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 210538
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 | Zydus Lifesciences Limited | 70771-1531 |
| dimethyl fumarate | Dimethyl fumarate 120 mg/1 | Capsule, Delayed releaseOral | Zydus Lifesciences Limited | 70771-1530 |
| dimethyl fumarate | Dimethyl fumarate 240 mg/1 | Capsule, Delayed releaseOral | Zydus Pharmaceuticals USA Inc. | 70710-1205 |