EBANGA

Product NDC: 80673-777
Requested package NDC: 80673-777-04
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	80673-777	80673-777-04	I	Inactivated by FDA		2026-10-05

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 date	Snapshot	Source SHA-256
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`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 concept	Relation	Version	Effective
e27dad47-ba41-41d1-8479-77ef8fe157da	Product name	1	20210609
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
80673-777-01	2025-02-10	These 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
80673-777-04	2025-02-10	These 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
80673-777-08	2025-02-10	These 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
80673-777-01	2024-01-30	These 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
80673-777-04	2024-01-30	These 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
80673-777-08	2024-01-30	These 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 NDC	Product	Description	Form	Quantity	Strength	SPL version
80673-001-01	EBANGA	8 mL in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, LYOPHILIZED,	288 mL	400 mg in 8mL	5
80673-001-36	EBANGA	36 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,		400 mg in 8mL	5
80673-777-01	EBANGA	1 in 1 CARTON	KIT	1		5
80673-777-01	EBANGA	1 in 1 BOX	KIT	1		5
80673-777-04	EBANGA	4 in 1 BOX	KIT	4		5
80673-777-04	EBANGA	1 in 1 CARTON	KIT	1		5
80673-777-08	EBANGA	1 in 1 CARTON	KIT	1		5
80673-777-08	EBANGA	8 in 1 BOX	KIT	8		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80673-777	EBANGA (ANSUVIMAB) KIT [RIDGEBACK BIOTHERAPEUTICS, LP]	5	Legacy NDC, 8 package rows	20250212_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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ebanga	ANSUVIMAB	Emergent BioDefense Operations Lansing LLC	de220c8f-ffcb-4522-a6a2-c7d6ce5de1b5	2026-08-13	Warnings, Adverse reactions	Exact identifier application number: BLA761172

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#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2472156	ansuvimab-zykl 400 MG Injection	PSN	9c008384-379d-48d3-b5a5-9809ed0f655c	5
2472161	ebanga 400 MG Injection	PSN	9c008384-379d-48d3-b5a5-9809ed0f655c	5
2472161	ansuvimab-zykl 400 MG Injection [Ebanga]	SBD	9c008384-379d-48d3-b5a5-9809ed0f655c	5
2472156	ansuvimab-zykl 400 MG Injection	SCD	9c008384-379d-48d3-b5a5-9809ed0f655c	5
2472161	Ebanga 400 MG Injection	SY	9c008384-379d-48d3-b5a5-9809ed0f655c	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
80673-777-04	80673077704	4 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 carton	2020-12-21	0000-00-00	No	No	Current