Home NDC 47783-101 Kalbitor
Product NDC 47783-101
11-digit product format 477830101
Labeler code 47783
Product ID 47783-101_1992039f-246f-4057-899b-987d45df152f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ecallantide
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler Takeda Pharmaceuticals America, Inc.
Application BLA125277
Marketing category BLA
Marketing start 2010-02-02
Substance ECALLANTIDE
Active strength 10 mg/mL
Pharmacologic classes Kallikrein Inhibitors [MoA], Plasma Kallikrein Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Kalbitor
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ECALLANTIDE 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5Q6TZN2HNM Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 884698 Internal RxNorm lookup 884702 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 47783-101-01 Kalbitor 3 in 1 CARTON INJECTION, SOLUTION 3 19 47783-101-01 Kalbitor 1 mL in 1 VIAL, GLASS INJECTION, SOLUTION 1 19
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ECALLANTIDE ACTIVE INGREDIENT 5Q6TZN2HNM KALBITOR (ECALLANTIDE) INJECTION, SOLUTION [DYAX CORP.] 10 ECALLANTIDE ACTIVE MOIETY 5Q6TZN2HNM KALBITOR (ECALLANTIDE) INJECTION, SOLUTION [DYAX CORP.] 10 POTASSIUM CHLORIDE INACTIVE INGREDIENT 660YQ98I10 KALBITOR (ECALLANTIDE) INJECTION, SOLUTION [DYAX CORP.] 10 POTASSIUM PHOSPHATE, MONOBASIC INACTIVE INGREDIENT 4J9FJ0HL51 KALBITOR (ECALLANTIDE) INJECTION, SOLUTION [DYAX CORP.] 10 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X KALBITOR (ECALLANTIDE) INJECTION, SOLUTION [DYAX CORP.] 10 SODIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT 94255I6E2T KALBITOR (ECALLANTIDE) INJECTION, SOLUTION [DYAX CORP.] 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 47783-101 KALBITOR (ECALLANTIDE) INJECTION, SOLUTION [TAKEDA PHARMACEUTICALS AMERICA, INC.] 18 Current NDC, Legacy NDC, 2 package rows 20231222_f56aec67-c662-477c-b866-bfc23e8809cf.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Kalbitor ECALLANTIDE Takeda Pharmaceuticals America, Inc. f56aec67-c662-477c-b866-bfc23e8809cf 2025-07-01 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA125277 ndc (product): 47783-101
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125277 Kalbitor ecallantide 351(a) Rx 2026-09-01
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 47783-101-01 47783010101 3 VIAL, GLASS in 1 CARTON (47783-101-01) / 1 mL in 1 VIAL, GLASS 2010-02-02 0000-00-00 No No Current