Home NDC 57894-801 IMAAVY
Product NDC 57894-801
11-digit product format 578940801
Labeler code 57894
Product ID 57894-801_d235e5b0-4de6-4235-92ef-ed05fa5892b2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name nipocalimab-aahu
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler Janssen Biotech, Inc.
Application BLA761430
Marketing category BLA
Marketing start 2025-04-29
Substance NIPOCALIMAB
Active strength 185 mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base IMAAVY
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NIPOCALIMAB 185 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 87M90CV8NC Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2712699 Internal RxNorm lookup 2712706 Internal RxNorm lookup 2712708 Internal RxNorm lookup 2712709 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 57894-801-01 IMAAVY 6.5 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION, CONCENTRATE 6.5 4 57894-801-01 IMAAVY 1 in 1 BOX INJECTION, SOLUTION, CONCENTRATE 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57894-801 IMAAVY (NIPOCALIMAB) INJECTION, SOLUTION, CONCENTRATE [JANSSEN BIOTECH, INC.] 2 Current NDC, 2 package rows 20250507_8886274c-f2b2-48af-85c1-2f90bfe304b8.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.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761430 Imaavy nipocalimab-aahu 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 Sample Exclude flag Status 57894-801-01 57894080101 1 VIAL, SINGLE-DOSE in 1 BOX (57894-801-01) / 6.5 mL in 1 VIAL, SINGLE-DOSE 2025-04-29 No No Current