Prescription drug · NDA
Gilenya (Fingolimod hcl) NDC 0078-0607
Fingolimod hydrochloride .5 mg/1 · Capsule · Oral · Novartis Pharmaceuticals Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0078-0607-15 | 00078060715 | 30 CAPSULE in 1 BOTTLE (0078-0607-15)Marketed from Sep 21, 2010 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Gilenya
- Generic name (nonproprietary)
- fingolimod hcl
- Active ingredients
- Fingolimod hydrochloride — .5 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Novartis Pharmaceuticals CorporationNDC labeler code 0078
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022527
- Marketing start
- Listing expires
- Other FDA classes
- Sphingosine 1-Phosphate Receptor Modulators (Mechanism)
- Identifiers
- Product ID 0078-0607_160c27a2-4788-441a-ac42-674e5aec433bSPL ID 160c27a2-4788-441a-ac42-674e5aec433bSPL set ID cc9e1c8c-0e2b-44e2-878b-27057f786be9RxCUI 1012895, 1012899, 2045491, 2045493UNII G926EC510T
- 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
N400078060715followed by a unit qualifier and the quantityPackage 00078-0607-15. 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)
GILENYA 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 patients 10 years of age and older. GILENYA is 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.
About NDC 0078-0607
- What is NDC 0078-0607?
- 0078-0607 is the product NDC for Gilenya (fingolimod hcl), Fingolimod hydrochloride .5 mg/1 capsule, listed with the FDA by Novartis Pharmaceuticals Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Gilenya (Fingolimod hcl).
- What is the active ingredient?
- Fingolimod hydrochloride.
- Who is the labeler?
- Novartis Pharmaceuticals Corporation, NDC labeler code 0078. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Gilenya?
- 1 other product NDC are listed under this name. See all Gilenya NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Gilenya products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Gilenyafingolimod hcl | Fingolimod hydrochloride .25 mg/1 | CapsuleOral | Novartis Pharmaceuticals Corporation | 0078-0965 | 00078-0965-89 |
Other NDCs under NDA 022527
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 |
|---|---|---|---|---|
| Gilenyafingolimod hcl | Fingolimod hydrochloride .25 mg/1 | CapsuleOral | Novartis Pharmaceuticals Corporation | 0078-0965 |