RabAvert

Product NDC: 58160-964
Requested package NDC: 58160-964-12
11-digit product format: 581600964
Labeler code: 58160
Product ID: 58160-964_6aaf45e1-7af5-4d94-be4f-72eeadc2e0d9
Type: VACCINE
Nonproprietary name: Rabies Vaccine
Dosage form: KIT
Labeler: GlaxoSmithKline Biologicals SA
Application: BLA103334
Marketing category: BLA
Marketing start: 2016-12-19
Marketing end: 2024-01-31
Active strength: 0
NDC exclude flag: No
Listing certified through: 0000-00-00
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	58160-964	58160-964-12	D	Discontinued by firm		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 · 12 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
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
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…`

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
77dc03a4-fbfc-e6a3-fe95-285bbae40d75	Product name	2	20250814

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58160-964-12	EA - Each	58160-964	fce952e5-f786-4812-8fd8-98ecf0fcc1df	1	2017-05-04

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
103334	Rabavert	Rabies Vaccine	351(a)	Rx	2026-09-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
830463	RabAvert 2.5 UNT in 1 ML Injection	PSN	fd2f21f0-9f8e-4abd-b603-e1834a252c2d	3
830460	rabies virus vaccine (generic for Rabavert) 2.5 UNT in 1 ML Injection	PSN	fd2f21f0-9f8e-4abd-b603-e1834a252c2d	3
830463	1 ML rabies virus vaccine flury-lep strain 2.5 UNT/ML Injection [RabAvert]	SBD	fd2f21f0-9f8e-4abd-b603-e1834a252c2d	3
830460	1 ML rabies virus vaccine flury-lep strain 2.5 UNT/ML Injection	SCD	fd2f21f0-9f8e-4abd-b603-e1834a252c2d	3
830463	1 ML RabAvert 2.5 UNT/ML Injection	SY	fd2f21f0-9f8e-4abd-b603-e1834a252c2d	3
830463	RabAvert 2.5 UNT per 1 ML Injection	SY	fd2f21f0-9f8e-4abd-b603-e1834a252c2d	3
830460	rabies virus vaccine flury-lep strain 2.5 UNT per 1 ML Injection	SY	fd2f21f0-9f8e-4abd-b603-e1834a252c2d	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58160-964-12	58160096412	1 KIT in 1 CARTON (58160-964-12) * 1 mL in 1 VIAL, GLASS (58160-966-01) * 1 mL in 1 SYRINGE (58160-967-02)	1 kit	2016-12-19	2024-01-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
RabAvert	A-S Medication Solutions	2020-01-18	VACCINE LABEL	3
RabAvert	GlaxoSmithKline Biologicals SA	2019-09-18	VACCINE LABEL	8