Home NDC 69604-204 Anthim
Product NDC 69604-204
11-digit product format 696040204
Labeler code 69604
Product ID 69604-204_90524689-1977-4c22-b849-8aaa5f969adf
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 2026-12-31
Current FDA listing Yes openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 Anthim OBILTOXAXIMAB Elusys Therapeutics, Inc. 39ad8799-00a4-4fc8-9852-c0536350c474 2025-11-17 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA125509 ndc (product): 69604-204
Additional Listing Data#
Finished product Yes
Brand name base Anthim
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OBILTOXAXIMAB 100 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 29Z5DNL48C Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1746910 Internal RxNorm lookup 1746915 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69604-204-02 Anthim 1 in 1 CARTON SOLUTION 1 9 69604-204-02 Anthim 6 mL in 1 VIAL, SINGLE-USE SOLUTION 6 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69604-204 ANTHIM (OBILTOXAXIMAB) SOLUTION [ELUSYS THERAPEUTICS, INC.] 8 Current NDC, Legacy NDC, 2 package rows 20230617_39ad8799-00a4-4fc8-9852-c0536350c474.zip
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125509 Anthim obiltoxaximab 351(a) Rx 2026-06-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 69604-204-02 69604020402 1 VIAL, SINGLE-USE in 1 CARTON (69604-204-02) / 6 mL in 1 VIAL, SINGLE-USE 2016-03-18 0000-00-00 No No Current