Prescription drug · ANDA
Dimethyl Fumarate NDC 31722-680
Kit · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-680-60 | 31722068060 | 1 KIT in 1 KIT (31722-680-60) * 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE * 46 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Sep 24, 2020 |
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
- Labeler
- Camber Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210500
- Marketing start
- Listing expires
- Identifiers
- Product ID 31722-680_1814ba82-76cc-c580-e063-6294a90a5e57SPL ID 1814ba82-76cc-c580-e063-6294a90a5e57SPL set ID b856ac70-71cd-477b-95b1-0a6132c260e8RxCUI 1373483, 1373491, 1373497UNII FO2303MNI2UPC 0331722657310, 0331722658324, 0331722658317
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
N431722068060followed by a unit qualifier and the quantityPackage 31722-0680-60. 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 210500
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 | Quallent Pharmaceuticals Health LLC | 82009-138 |
| Dimethyl Fumarate | Dimethyl fumarate 240 mg/1 | Capsule, Delayed releaseOral | Camber Pharmaceuticals, Inc. | 31722-658 |
| Dimethyl Fumarate | Dimethyl fumarate 120 mg/1 | Capsule, Delayed releaseOral | Camber Pharmaceuticals, Inc. | 31722-657 |
| Dimethyl Fumarate | Dimethyl fumarate 240 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-5288 |