FDA.reportPublic FDA data

EBANGA

Product NDC
80673-777
11-digit product format
806730777
Labeler code
80673
Product ID
80673-777_2dcc24f9-c86e-1693-e063-6394a90ac147
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ANSUVIMAB
Dosage form
KIT
Labeler
Ridgeback Biotherapeutics, LP
Application
BLA761172
Marketing category
BLA
Marketing start
2020-12-21
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
EBANGA
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui2472156, 2472161

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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80673-777-012025-02-10C16284748780-11030e365-559a-111a-e063-dadaa90a10e2These 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
80673-777-042025-02-10C16284748780-11030e365-559a-111a-e063-dadaa90a10e2These 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
80673-777-082025-02-10C16284748780-11030e365-559a-111a-e063-dadaa90a10e2These 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
80673-777-012024-01-30C16284748780-11030e365-559a-111a-e063-dadaa90a10e2These 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
80673-777-042024-01-30C16284748780-11030e365-559a-111a-e063-dadaa90a10e2These 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
80673-777-082024-01-30C16284748780-11030e365-559a-111a-e063-dadaa90a10e2These 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]5Current NDC, Legacy NDC, 8 package rows20250212_9c008384-379d-48d3-b5a5-9809ed0f655c.zip

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
80673-001-01806730001018 mL in 1 VIAL, SINGLE-DOSE8 mlHistorical
80673-001-368067300013636 in 1 CARTONHistorical
80673-777-01806730777011 CARTON in 1 BOX (80673-777-01) / 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) 1 carton2020-12-210000-00-00NoNoCurrent
80673-777-04806730777044 CARTON in 1 BOX (80673-777-04) / 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) 4 carton2020-12-210000-00-00NoNoCurrent
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