FDA.reportPublic FDA data

Anthim

Product NDC
69604-204
11-digit product format
696040204
Labeler code
69604
Product ID
69604-204_a68128d1-0195-4846-a767-d21a4ca98ba3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
obiltoxaximab
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
Elusys Therapeutics, Inc.
Application
BLA125509
Marketing category
BLA
Marketing start
2016-03-18
Substance
OBILTOXAXIMAB
Active strength
100 mg/mL
Pharmacologic classes
Anthrax Protective Antigen-directed Antibody Interactions [MoA], Anthrax Protective Antigen-directed Antibody [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Anthim
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OBILTOXAXIMAB100 mg/mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ecce15dc-3925-4e77-8156-0feec865ff13Product name120160502

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69604-204-022024-01-30C16284748780-11030e365-1f7c-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ANTHIM safely and effectively. See full prescribing information for ANTHIM. ANTHIM ® (obiltoxaximab) injection, for intravenous use Initial U.S. Approval: 2016
69604-204-022024-01-30C16284748780-11030e365-1f7c-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ANTHIM safely and effectively. See full prescribing information for ANTHIM. ANTHIM ® (obiltoxaximab) injection, for intravenous use Initial U.S. Approval: 2016
69604-204-022024-01-30C16284748780-11030e365-1f7c-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ANTHIM safely and effectively. See full prescribing information for ANTHIM. ANTHIM ® (obiltoxaximab) injection, for intravenous use Initial U.S. Approval: 2016

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69604-204-02Anthim1 in 1 CARTONSOLUTION19
69604-204-02Anthim6 mL in 1 VIAL, SINGLE-USESOLUTION69

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69604-204ANTHIM (OBILTOXAXIMAB) SOLUTION [ELUSYS THERAPEUTICS, INC.]8Current NDC, Legacy NDC, 2 package rows20230617_39ad8799-00a4-4fc8-9852-c0536350c474.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125509Anthimobiltoxaximab351(a)Rx2026-09-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1746915Anthim 600 MG in 6 ML InjectionPSN39ad8799-00a4-4fc8-9852-c0536350c4749
1746910obiltoxaximab 600 MG in 6 ML InjectionPSN39ad8799-00a4-4fc8-9852-c0536350c4749
17469156 ML obiltoxaximab 100 MG/ML Injection [Anthim]SBD39ad8799-00a4-4fc8-9852-c0536350c4749
17469106 ML obiltoxaximab 100 MG/ML InjectionSCD39ad8799-00a4-4fc8-9852-c0536350c4749
17469156 ML Anthim 100 MG/ML InjectionSY39ad8799-00a4-4fc8-9852-c0536350c4749
1746915Anthim 600 MG per 6 ML InjectionSY39ad8799-00a4-4fc8-9852-c0536350c4749
1746910obiltoxaximab 600 MG per 6 ML InjectionSY39ad8799-00a4-4fc8-9852-c0536350c4749

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69604-204-02696040204021 VIAL, SINGLE-USE in 1 CARTON (69604-204-02) / 6 mL in 1 VIAL, SINGLE-USE2016-03-180000-00-00NoNoCurrent