NDC 76075-103

KYPROLIS

Carfilzomib

KYPROLIS is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Onyx Pharmaceuticals, Inc.. The primary component is Carfilzomib.

• Product ID: 76075-103_024270e5-7be9-41e7-b851-673c3aa784e7
• NDC: 76075-103
• Product Type: Human Prescription Drug
• Proprietary Name: KYPROLIS
• Generic Name: Carfilzomib
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2018-05-23
• Marketing Category: NDA / NDA
• Application Number: NDA202714
• Labeler Name: Onyx Pharmaceuticals, Inc.
• Substance Name: CARFILZOMIB
• Active Ingredient Strength: 10 mg/5mL
• Pharm Classes: Proteasome Inhibitor [EPC], Proteasome Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 76075-103-01

1 VIAL, SINGLE-DOSE in 1 CARTON (76075-103-01) > 10 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2018-05-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 76075-103-01 [76075010301]

KYPROLIS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA202714
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-05-23

Drug Details

Active Ingredients

Ingredient	Strength
CARFILZOMIB	10 mg/5mL

OpenFDA Data

• SPL SET ID: ea66eb30-e665-4693-99a1-a9d3b4bbe2d6
• Manufacturer:
  • Onyx Pharmaceuticals, Inc.
• UNII:
  • 72X6E3J5AR
• RxNorm Concept Unique ID - RxCUI:
  • 1806934
  • 1806937
  • 1806940
  • 1806942
  • 2046642
  • 2046644

Pharmacological Class

• Proteasome Inhibitor [EPC]
• Proteasome Inhibitors [MoA]

NDC Crossover Matching brand name "KYPROLIS" or generic name "Carfilzomib"

NDC	Brand Name	Generic Name
76075-101	KYPROLIS	carfilzomib
76075-102	KYPROLIS	carfilzomib
76075-103	KYPROLIS	carfilzomib