Prescription drug · NDA
Kyprolis (carfilzomib) NDC 76075-103
Carfilzomib 10 mg/5mL · Injection, Powder, Lyophilized, For solution · Intravenous · Onyx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76075-103-01 | 76075010301 | 1 VIAL, SINGLE-DOSE in 1 CARTON (76075-103-01) / 10 mL in 1 VIAL, SINGLE-DOSEMarketed from May 23, 2018 | |
| 76075-103-21 | 76075010321 | 1 VIAL, SINGLE-DOSE in 1 CARTON (76075-103-21) / 10 mL in 1 VIAL, SINGLE-DOSEMarketed from Oct 1, 2025 |
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)
- Kyprolis
- Generic name (nonproprietary)
- carfilzomib
- Active ingredients
- Carfilzomib — 10 mg/5mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Onyx Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 202714
- Marketing start
- Listing expires
- Other FDA classes
- Proteasome Inhibitors (Mechanism)
- Identifiers
- Product ID 76075-103_600cd22c-3a74-442e-a65d-c06d47bb892aSPL ID 600cd22c-3a74-442e-a65d-c06d47bb892aSPL set ID ea66eb30-e665-4693-99a1-a9d3b4bbe2d6RxCUI 1806934, 1806937, 1806940, 1806942, 2046642, 2046644UNII 72X6E3J5AR
- Pharmacologic class
- Proteasome Inhibitor
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
N476075010301followed by a unit qualifier and the quantityPackage 76075-0103-01. 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)
Kyprolis is a proteasome inhibitor that is indicated: for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy in combination with Lenalidomide and dexamethasone; or Dexamethasone; or Daratumumab and dexamethasone; or Daratumumab and hyaluronidase-fihj and dexamethasone; or Isatuximab and dexamethasone. ( 1 , 14 ) as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy. ( 1 , 14 ) 1.1 Relapsed or Refractory Multiple Myeloma Kyprolis is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have rece…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 202714
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 |
|---|---|---|---|---|
| Kyproliscarfilzomib | Carfilzomib 60 mg/30mL | Injection, Powder, Lyophilized, For solutionIntravenous | Onyx Pharmaceuticals, Inc. | 76075-101 |
| Kyproliscarfilzomib | Carfilzomib 30 mg/15mL | Injection, Powder, Lyophilized, For solutionIntravenous | Onyx Pharmaceuticals, Inc. | 76075-102 |