Prescription drug · ANDA
Fingolimod NDC 43547-003
Fingolimod .5 mg/1 · Capsule · Oral · Solco Healthcare US, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43547-003-03 | 43547000303 | 30 CAPSULE in 1 BOTTLE (43547-003-03)Marketed from Oct 26, 2021 | |
| 43547-003-09 | 43547000309 | 90 CAPSULE in 1 BOTTLE (43547-003-09)Marketed from Oct 26, 2021 |
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)
- Fingolimod
- Generic name (nonproprietary)
- fingolimod
- Active ingredients
- Fingolimod — .5 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Solco Healthcare US, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208003
- Marketing start
- Listing expires
- Other FDA classes
- Sphingosine 1-Phosphate Receptor Modulators (Mechanism)
- Identifiers
- Product ID 43547-003_8a52d7dc-58d1-4dec-bfbd-5424ec30b984SPL ID 8a52d7dc-58d1-4dec-bfbd-5424ec30b984SPL set ID 6c0faf2b-21fb-4830-bb78-5f2dbceb2c82RxCUI 1012895UNII 3QN8BYN5QF
- Pharmacologic class
- Sphingosine 1-phosphate Receptor Modulator
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
N443547000303followed by a unit qualifier and the quantityPackage 43547-0003-03. 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)
Fingolimod 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 patients 10 years of age and older. Fingolimod capsules are a sphingosine 1-phosphate receptor modulator 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 patients 10 years of age and older. ( 1 )
Excerpt only. Read the full label for complete information.