Prescription drug · NDA
Nourianz (Istradefylline) NDC 42747-604
Istradefylline 40 mg/1 · Tablet, Film coated · Oral · Kyowa Kirin, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42747-604-07 | 42747060407 | 1 BLISTER PACK in 1 BOX (42747-604-07) / 7 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Aug 27, 2019 · Sample package | |
| 42747-604-90 | 42747060490 | 90 TABLET, FILM COATED in 1 BOTTLE (42747-604-90)Marketed from Aug 27, 2019 |
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)
- Nourianz
- Generic name (nonproprietary)
- istradefylline
- Active ingredients
- Istradefylline — 40 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Kyowa Kirin, Inc.NDC labeler code 42747
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022075
- Marketing start
- Listing expires
- Identifiers
- Product ID 42747-604_607b4223-661d-45e0-8209-99c5ba62d5c0SPL ID 607b4223-661d-45e0-8209-99c5ba62d5c0SPL set ID a7d008cb-b273-4049-a5d2-9c6902910d58RxCUI 2199020, 2199026, 2199028, 2199030UNII 2GZ0LIK7T4UPC 0342747604906, 0342747602902
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
N442747060407followed by a unit qualifier and the quantityPackage 42747-0604-07. 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)
NOURIANZ is indicated as adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson's disease (PD) experiencing "off" episodes. NOURIANZ is an adenosine receptor antagonist indicated as adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson's disease (PD) experiencing "off" episodes ( 1 ).
Excerpt only. Read the full label for complete information.
About NDC 42747-604
- What is NDC 42747-604?
- 42747-604 is the product NDC for Nourianz (istradefylline), Istradefylline 40 mg/1 tablet, film coated, listed with the FDA by Kyowa Kirin, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nourianz (Istradefylline).
- What is the active ingredient?
- Istradefylline.
- Who is the labeler?
- Kyowa Kirin, Inc., NDC labeler code 42747. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Nourianz?
- 1 other product NDC are listed under this name. See all Nourianz NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nourianz products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nourianzistradefylline | Istradefylline 20 mg/1 | Tablet, Film coatedOral | Kyowa Kirin, Inc. | 42747-602 | 42747-0602-0742747-0602-90 |
Other NDCs under NDA 022075
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 |
|---|---|---|---|---|
| Nourianzistradefylline | Istradefylline 20 mg/1 | Tablet, Film coatedOral | Kyowa Kirin, Inc. | 42747-602 |