Home NDC 83000-110-04 GOHIBIC
Product NDC 83000-110
Requested package NDC 83000-110-04
11-digit product format 830000110
Labeler code 83000
Product ID 83000-110_2c67a1db-151c-d067-e063-6394a90a5b06
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name vilobelimab
Dosage form INJECTION
Route INTRAVENOUS
Labeler InflaRx GmbH
Marketing category EMERGENCY USE AUTHORIZATION
Marketing start 2023-04-04
Substance VILOBELIMAB
Active strength 10 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 83000-110 83000-110-04 U Excluded because listing certification expired excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 83000-110 83000-110-04 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
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 GOHIBIC
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VILOBELIMAB 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F5T0RF9ZJA Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2639630 Internal RxNorm lookup 2639636 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83000-110-04 GOHIBIC 4 in 1 CARTON INJECTION 4 7 83000-110-04 GOHIBIC 20 mL in 1 VIAL, SINGLE-DOSE INJECTION 20 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83000-110 GOHIBIC (VILOBELIMAB) INJECTION [INFLARX GMBH] 7 Current NDC, 2 package rows 20250125_6a571038-1f6c-4e66-937c-ddf6e2a4e30a.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 83000-110-04 83000011004 4 VIAL, SINGLE-DOSE in 1 CARTON (83000-110-04) / 20 mL in 1 VIAL, SINGLE-DOSE 2023-04-04 No No Current