Prescription drug · NDA
Korsuva (Difelikefalin) NDC 59353-065
Difelikefalin acetate 50 ug/mL · Injection, Solution · Intravenous · Vifor (International), Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59353-065-12 | 5935300651259353006512 | 12 VIAL, SINGLE-USE in 1 TRAY (59353-065-12) / 1.3 mL in 1 VIAL, SINGLE-USE (59353-065-01)Marketed from Nov 1, 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)
- Korsuva
- Generic name (nonproprietary)
- difelikefalin
- Active ingredients
- Difelikefalin acetate — 50 ug/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Vifor (International), Inc.NDC labeler code 59353
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 214916
- Marketing start
- Listing expires
- Other FDA classes
- Opioid kappa Receptor Agonists (Mechanism)
- Identifiers
- Product ID 59353-065_1d0f4d9e-7a5e-4320-96ca-da538aec0c2fSPL ID 1d0f4d9e-7a5e-4320-96ca-da538aec0c2fSPL set ID 0c7b81f2-0fd3-47cb-8b0f-185e07f19c87RxCUI 2569094, 2569100UNII 0P70AR5BYB
- Pharmacologic class
- Kappa Opioid Receptor Agonist
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.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N459353006512followed by a unit qualifier and the quantityPackage 59353-0065-12. 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)
KORSUVA is indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis (HD). KORSUVA is a kappa opioid receptor agonist indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis (HD). ( 1 ) Limitation of Use Korsuva has not been studied in patients on peritoneal dialysis and is not recommended for use in this population. ( 1 ) Limitations of Use KORSUVA has not been studied in patients on peritoneal dialysis and is not recommended for use in this population.
Excerpt only. Read the full label for complete information.
About NDC 59353-065
- What is NDC 59353-065?
- 59353-065 is the product NDC for Korsuva (difelikefalin), Difelikefalin acetate 50 ug/mL injection, solution, listed with the FDA by Vifor (International), Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Korsuva (Difelikefalin).
- What is the active ingredient?
- Difelikefalin acetate.
- Who is the labeler?
- Vifor (International), Inc., NDC labeler code 59353. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Korsuva?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.