FDA.reportPublic FDA data

Raxibacumab

Product NDC
49401-103
Requested package NDC
49401-103-01
11-digit product format
494010103
Labeler code
49401
Product ID
49401-103_7ca23f5f-4c47-4280-a2e8-433b69e1f5cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
raxibacumab
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Human Genome Sciences, Inc.
Application
BLA125349
Marketing category
BLA
Marketing start
2012-12-14
Marketing end
2022-05-31
Substance
RAXIBACUMAB
Active strength
50 mg/mL
Pharmacologic classes
Anthrax Protective Antigen-directed Antibody [EPC],Anthrax Protective Antigen-directed Antibody Interactions [MoA]
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage49401-10349401-103-01DDiscontinued by firm2026-10-05

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 dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
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…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RAXIBACUMABACTIVE INGREDIENT794PGL549SRAXIBACUMAB INJECTION [HUMAN GENOME SCIENCES, INC.]6
RAXIBACUMABACTIVE MOIETY794PGL549SRAXIBACUMAB INJECTION [HUMAN GENOME SCIENCES, INC.]6
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPRAXIBACUMAB INJECTION [HUMAN GENOME SCIENCES, INC.]6
GLYCINEINACTIVE INGREDIENTTE7660XO1CRAXIBACUMAB INJECTION [HUMAN GENOME SCIENCES, INC.]6
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HRAXIBACUMAB INJECTION [HUMAN GENOME SCIENCES, INC.]6
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRRAXIBACUMAB INJECTION [HUMAN GENOME SCIENCES, INC.]6
SUCROSEINACTIVE INGREDIENTC151H8M554RAXIBACUMAB INJECTION [HUMAN GENOME SCIENCES, INC.]6

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125349raxibacumab351(a)Rx2026-09-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49401-103-01494010103011 VIAL, SINGLE-USE in 1 CARTON (49401-103-01) > 34 mL in 1 VIAL, SINGLE-USE2012-12-142022-05-31NoNoCurrent