KYPROLIS
- Product NDC
- 76075-103
- 11-digit product format
- 760750103
- Labeler code
- 76075
- Product ID
- 76075-103_600cd22c-3a74-442e-a65d-c06d47bb892a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- carfilzomib
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Onyx Pharmaceuticals, Inc.
- Application
- NDA202714
- Marketing category
- NDA
- Marketing start
- 2018-05-23
- Substance
- CARFILZOMIB
- Active strength
- 10 mg/5mL
- Pharmacologic classes
- Proteasome Inhibitor [EPC], Proteasome Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- KYPROLIS
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CARFILZOMIB | 10 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 72X6E3J5AR |
| Rxcui | 1806934, 1806937, 1806940, 1806942, 2046642, 2046644 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76075-103-01 | KYPROLIS | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 59 |
| 76075-103-01 | KYPROLIS | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 10 | | 59 |
| 76075-103-21 | KYPROLIS | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 59 |
| 76075-103-21 | KYPROLIS | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 10 | | 59 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CARFILZOMIB | ACTIVE INGREDIENT | 72X6E3J5AR | KYPROLIS (CARFILZOMIB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ONYX PHARMACEUTICALS, INC.] | 8 | |
| CARFILZOMIB | ACTIVE MOIETY | 72X6E3J5AR | KYPROLIS (CARFILZOMIB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ONYX PHARMACEUTICALS, INC.] | 8 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | KYPROLIS (CARFILZOMIB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ONYX PHARMACEUTICALS, INC.] | 8 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | KYPROLIS (CARFILZOMIB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ONYX PHARMACEUTICALS, INC.] | 8 | |
| SULFOBUTYLETHER .BETA.-CYCLODEXTRIN | INACTIVE INGREDIENT | 2PP9364507 | KYPROLIS (CARFILZOMIB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ONYX PHARMACEUTICALS, INC.] | 8 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | KYPROLIS (CARFILZOMIB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ONYX PHARMACEUTICALS, INC.] | 8 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76075-103 | KYPROLIS (CARFILZOMIB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ONYX PHARMACEUTICALS, INC.] | 55 | Current NDC, Legacy NDC, 4 package rows | 20240926_ea66eb30-e665-4693-99a1-a9d3b4bbe2d6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 76075-103-01 | 76075010301 | 1 VIAL, SINGLE-DOSE in 1 CARTON (76075-103-01) / 10 mL in 1 VIAL, SINGLE-DOSE | 2018-05-23 | 0000-00-00 | No | No | Current |
| 76075-103-21 | 76075010321 | 1 VIAL, SINGLE-DOSE in 1 CARTON (76075-103-21) / 10 mL in 1 VIAL, SINGLE-DOSE | 2025-10-01 | | No | No | Current |