Prescription drug · ANDA
Dimethyl Fumarate NDC 70512-852
Dimethyl fumarate 120 mg/1 · Capsule, Delayed release · Oral · SOLA Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70512-852-14 | 70512085214 | 1 BOTTLE in 1 CARTON (70512-852-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Mar 12, 2023 |
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
- SOLA Pharmaceuticals, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210436
- Marketing start
- Listing expires
- Identifiers
- Product ID 70512-852_457243f3-2d22-3222-e063-6394a90ae21eSPL ID 457243f3-2d22-3222-e063-6394a90ae21eSPL set ID b4a200c1-f25a-4aa8-8770-06182fdeda9dRxCUI 1373483, 1373491UNII 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
N470512085214followed by a unit qualifier and the quantityPackage 70512-0852-14. 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 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.
Other NDCs under ANDA 210436
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 | SOLA Pharmaceuticals, LLC | 70512-853 |