Prescription drug · ANDA
Dimethyl Fumarate (dimethyl fumarate kit) NDC 68462-570
Kit · Glenmark Pharmaceuticals Inc., USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68462-570-78 | 68462057078 | 1 KIT in 1 KIT (68462-570-78) * 14 CAPSULE in 1 BOTTLE * 46 CAPSULE in 1 BOTTLEMarketed from Oct 6, 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 kit
- Dosage form
- Kit
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210309
- Marketing start
- Listing expires
- Identifiers
- Product ID 68462-570_74611591-657b-40e8-8ae1-1e5533a05d97SPL ID 74611591-657b-40e8-8ae1-1e5533a05d97SPL set ID c3f65da9-f5f4-4161-aded-c23b16fd49edRxCUI 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 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
N468462057078followed by a unit qualifier and the quantityPackage 68462-0570-78. 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 210309
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 Fumaratedimethyl-fumarate | Dimethyl fumarate 120 mg/1 | CapsuleOral | Glenmark Pharmaceuticals Inc., USA | 68462-307 |
| Dimethyl Fumaratedimethyl-fumarate | Dimethyl fumarate 240 mg/1 | CapsuleOral | Glenmark Pharmaceuticals Inc., USA | 68462-308 |