FDA.reportPublic FDA data

EBANGA

Product NDC
80673-777
Requested package NDC
80673-777-08
11-digit product format
806730777
Labeler code
80673
Product ID
80673-777_dfb0b100-bfbb-4abb-e053-2a95a90ab90c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ANSUVIMAB
Dosage form
KIT
Labeler
Ridgeback Biotherapeutics, LP
Application
BLA761172
Marketing category
BLA
Marketing start
2020-12-21
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage80673-77780673-777-08IInactivated by FDA2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e27dad47-ba41-41d1-8479-77ef8fe157daProduct name120210609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
80673-777-012025-02-10These highlights do not include all the information needed to use EBANGA™ safely and effectively. See full prescribing information for EBANGA. EBANGA (ansuvimab-zykl) for injection, for intravenous use Initial U.S. Approval: 2020
80673-777-042025-02-10These highlights do not include all the information needed to use EBANGA™ safely and effectively. See full prescribing information for EBANGA. EBANGA (ansuvimab-zykl) for injection, for intravenous use Initial U.S. Approval: 2020
80673-777-082025-02-10These highlights do not include all the information needed to use EBANGA™ safely and effectively. See full prescribing information for EBANGA. EBANGA (ansuvimab-zykl) for injection, for intravenous use Initial U.S. Approval: 2020
80673-777-012024-01-30These highlights do not include all the information needed to use EBANGA™ safely and effectively. See full prescribing information for EBANGA. EBANGA (ansuvimab-zykl) for injection, for intravenous use Initial U.S. Approval: 2020
80673-777-042024-01-30These highlights do not include all the information needed to use EBANGA™ safely and effectively. See full prescribing information for EBANGA. EBANGA (ansuvimab-zykl) for injection, for intravenous use Initial U.S. Approval: 2020
80673-777-082024-01-30These highlights do not include all the information needed to use EBANGA™ safely and effectively. See full prescribing information for EBANGA. EBANGA (ansuvimab-zykl) for injection, for intravenous use Initial U.S. Approval: 2020

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80673-001-01EBANGA8 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,288 mL400 mg in 8mL5
80673-001-36EBANGA36 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,400 mg in 8mL5
80673-777-01EBANGA1 in 1 CARTONKIT15
80673-777-01EBANGA1 in 1 BOXKIT15
80673-777-04EBANGA4 in 1 BOXKIT45
80673-777-04EBANGA1 in 1 CARTONKIT15
80673-777-08EBANGA1 in 1 CARTONKIT15
80673-777-08EBANGA8 in 1 BOXKIT85

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80673-777EBANGA (ANSUVIMAB) KIT [RIDGEBACK BIOTHERAPEUTICS, LP]5Legacy NDC, 8 package rows20250212_9c008384-379d-48d3-b5a5-9809ed0f655c.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EbangaANSUVIMABEmergent BioDefense Operations Lansing LLCde220c8f-ffcb-4522-a6a2-c7d6ce5de1b52026-08-13Warnings, Adverse reactionsExact identifier
application number: BLA761172

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761172Ebangaansuvimab-zykl351(a)Rx2026-09-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2472156ansuvimab-zykl 400 MG InjectionPSN9c008384-379d-48d3-b5a5-9809ed0f655c5
2472161ebanga 400 MG InjectionPSN9c008384-379d-48d3-b5a5-9809ed0f655c5
2472161ansuvimab-zykl 400 MG Injection [Ebanga]SBD9c008384-379d-48d3-b5a5-9809ed0f655c5
2472156ansuvimab-zykl 400 MG InjectionSCD9c008384-379d-48d3-b5a5-9809ed0f655c5
2472161Ebanga 400 MG InjectionSY9c008384-379d-48d3-b5a5-9809ed0f655c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80673-777-08806730777088 CARTON in 1 BOX (80673-777-08) > 1 KIT in 1 CARTON * 36 VIAL, SINGLE-DOSE in 1 CARTON (80673-001-36) > 8 mL in 1 VIAL, SINGLE-DOSE (80673-001-01) 8 carton2020-12-210000-00-00NoNoCurrent