kalbitor

Generic: ecallantide

Labeler: takeda pharmaceuticals america, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name kalbitor
Generic Name ecallantide
Labeler takeda pharmaceuticals america, inc.
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

ecallantide 10 mg/mL

Manufacturer
Takeda Pharmaceuticals America, Inc.

Identifiers & Regulatory

Product NDC 47783-101
Product ID 47783-101_1992039f-246f-4057-899b-987d45df152f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125277
Listing Expiration 2026-12-31
Marketing Start 2010-02-02

Pharmacologic Class

Established (EPC)
plasma kallikrein inhibitor [epc]
Mechanism of Action
kallikrein inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 47783101
Hyphenated Format 47783-101

Supplemental Identifiers

RxCUI
884698 884702
UNII
5Q6TZN2HNM
NUI
N0000192750 N0000184151

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name kalbitor (source: ndc)
Generic Name ecallantide (source: ndc)
Application Number BLA125277 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 3 VIAL, GLASS in 1 CARTON (47783-101-01) / 1 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

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

Ingredients (1)

ecallantide (10 mg/mL)

Linked Drug Pages (1)

Kalbitor ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "1992039f-246f-4057-899b-987d45df152f", "openfda": {"nui": ["N0000192750", "N0000184151"], "unii": ["5Q6TZN2HNM"], "rxcui": ["884698", "884702"], "spl_set_id": ["f56aec67-c662-477c-b866-bfc23e8809cf"], "pharm_class_epc": ["Plasma Kallikrein Inhibitor [EPC]"], "pharm_class_moa": ["Kallikrein Inhibitors [MoA]"], "manufacturer_name": ["Takeda Pharmaceuticals America, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 VIAL, GLASS in 1 CARTON (47783-101-01)  / 1 mL in 1 VIAL, GLASS", "package_ndc": "47783-101-01", "marketing_start_date": "20100202"}], "brand_name": "Kalbitor", "product_id": "47783-101_1992039f-246f-4057-899b-987d45df152f", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Kallikrein Inhibitors [MoA]", "Plasma Kallikrein Inhibitor [EPC]"], "product_ndc": "47783-101", "generic_name": "Ecallantide", "labeler_name": "Takeda Pharmaceuticals America, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Kalbitor", "active_ingredients": [{"name": "ECALLANTIDE", "strength": "10 mg/mL"}], "application_number": "BLA125277", "marketing_category": "BLA", "marketing_start_date": "20100202", "listing_expiration_date": "20261231"}