NDC 47783-101

Kalbitor

Ecallantide

Kalbitor is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Takeda Pharmaceuticals America, Inc.. The primary component is Ecallantide.

• Product ID: 47783-101_12a8d1d0-f872-45fb-bb3c-926cc549fd1e
• NDC: 47783-101
• Product Type: Human Prescription Drug
• Proprietary Name: Kalbitor
• Generic Name: Ecallantide
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2010-02-02
• Marketing Category: BLA / BLA
• Application Number: BLA125277
• Labeler Name: Takeda Pharmaceuticals America, Inc.
• Substance Name: ECALLANTIDE
• Active Ingredient Strength: 10 mg/mL
• Pharm Classes: Kallikrein Inhibitors [MoA], Plasma Kallikrein Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 47783-101-01

3 VIAL, GLASS in 1 CARTON (47783-101-01) > 1 mL in 1 VIAL, GLASS

• Marketing Start Date: 2010-02-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 47783-101-01 [47783010101]

KALBITOR INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125277
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2010-02-02

Drug Details

Active Ingredients

Ingredient	Strength
ECALLANTIDE	10 mg/mL

OpenFDA Data

• SPL SET ID: f56aec67-c662-477c-b866-bfc23e8809cf
• Manufacturer:
  • Dyax Corp.
• UNII:
  • 5Q6TZN2HNM
• RxNorm Concept Unique ID - RxCUI:
  • 884698
  • 884702

Pharmacological Class

• Plasma Kallikrein Inhibitor [EPC]
• Kallikrein Inhibitors [MoA]
• Plasma Kallikrein Inhibitor [EPC]
• Kallikrein Inhibitors [MoA]