RabAvert

Product NDC: 63851-501
11-digit product format: 638510501
Labeler code: 63851
Product ID: 63851-501_1e6d0596-d032-4f29-a94b-ca5ce32abe23
Type: VACCINE
Nonproprietary name: Rabies Vaccine
Dosage form: KIT
Labeler: GSK Vaccines GmbH
Application: BLA103334
Marketing category: BLA
Marketing start: 2014-07-08
Marketing end: 2020-03-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63851-501		D	Discontinued by firm		2026-10-05
excluded package	package	63851-501	63851-501-02	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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63851-501-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63851-501-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63851-501-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63851-501-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63851-501-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63851-501-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63851-501-02	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63851-501-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63851-501-02	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63851-501-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63851-501-02	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63851-501-02	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63851-501-01	EA - Each	63851-501	12e0e203-af24-45e7-8d04-88cc5ddc4b57	1	2013-02-19
63851-501-02	EA - Each	63851-501	f2c9bf1c-e5e8-4f57-bca3-ff1d260e1fbf	1	2014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
RABIES VIRUS STRAIN FLURY LEP ANTIGEN (PROPIOLACTONE INACTIVATED)	ACTIVE INGREDIENT	FK894Q51YE	RABAVERT (RABIES VACCINE) KIT [NOVARTIS VACCINES AND DIAGNOSTICS GMBH]	10
RABIES VIRUS STRAIN FLURY LEP ANTIGEN (PROPIOLACTONE INACTIVATED)	ACTIVE MOIETY	FK894Q51YE	RABAVERT (RABIES VACCINE) KIT [NOVARTIS VACCINES AND DIAGNOSTICS GMBH]	10
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	RABAVERT (RABIES VACCINE) KIT [NOVARTIS VACCINES AND DIAGNOSTICS GMBH]	10
POTASSIUM GLUCONATE	INACTIVE INGREDIENT	12H3K5QKN9	RABAVERT (RABIES VACCINE) KIT [NOVARTIS VACCINES AND DIAGNOSTICS GMBH]	10
Sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	RABAVERT (RABIES VACCINE) KIT [NOVARTIS VACCINES AND DIAGNOSTICS GMBH]	10
Tromethamine	INACTIVE INGREDIENT	023C2WHX2V	RABAVERT (RABIES VACCINE) KIT [NOVARTIS VACCINES AND DIAGNOSTICS GMBH]	10

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
RabAvert ® Rabies Vaccine	A-S Medication Solutions	2017-12-11	VACCINE LABEL	6
RabAvert ® Rabies Vaccine	GSK Vaccines GmbH	2014-07-22	VACCINE LABEL	12