Home NDC 71655-578-04 Ebanga
Product NDC 71655-578
Requested package NDC 71655-578-04
11-digit product format 716550578
Labeler code 71655
Product ID 71655-578_58f2d4af-2a78-c5f5-e063-6294a90a36bb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ansuvimab
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Emergent BioDefense Operations Lansing LLC
Application BLA761172
Marketing category BLA
Marketing start 2020-12-21
Substance ANSUVIMAB
Active strength 400 mg/8mL
Pharmacologic classes Zaire Ebolavirus Glycoprotein-directed Antibody Interactions [MoA], Zaire Ebolavirus Glycoprotein-directed Antibody [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 Ebanga
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ANSUVIMAB 400 mg/8mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination TG8IQ19NG2 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2472156 Internal RxNorm lookup 2472161 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 71655-578-01 Ebanga 8 mL in 1 VIAL, GLASS INJECTION, POWDER, LYOPHILIZED, 8 2 71655-578-02 Ebanga 36 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 36 2 71655-578-03 Ebanga 1 in 1 BOX INJECTION, POWDER, LYOPHILIZED, 1 2 71655-578-04 Ebanga 4 in 1 BOX INJECTION, POWDER, LYOPHILIZED, 4 2 71655-578-08 Ebanga 8 in 1 BOX INJECTION, POWDER, LYOPHILIZED, 8 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71655-578 EBANGA (ANSUVIMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [EMERGENT MANUFACTURING OPERATIONS BALTIMORE, LLC] 1 Current NDC, 5 package rows 20250117_de220c8f-ffcb-4522-a6a2-c7d6ce5de1b5.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.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761172 Ebanga ansuvimab-zykl 351(a) Rx 2026-09-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 71655-578-04 71655057804 4 CARTON in 1 BOX (71655-578-04) / 36 VIAL, GLASS in 1 CARTON (71655-578-02) / 8 mL in 1 VIAL, GLASS (71655-578-01) 4 carton 2020-12-21 No No Current