imaavy

Generic: nipocalimab

Labeler: janssen biotech, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name imaavy
Generic Name nipocalimab
Labeler janssen biotech, inc.
Dosage Form INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients

nipocalimab 185 mg/mL

Manufacturer
Janssen Biotech, Inc.

Identifiers & Regulatory

Product NDC 57894-800
Product ID 57894-800_347a9376-5865-d57f-e063-6394a90a4ad4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761430
Listing Expiration 2026-12-31
Marketing Start 2025-04-29

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 57894800
Hyphenated Format 57894-800

Supplemental Identifiers

RxCUI
2712699 2712706 2712708 2712709
UNII
87M90CV8NC

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name imaavy (source: ndc)
Generic Name nipocalimab (source: ndc)
Application Number BLA761430 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 185 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 BOX (57894-800-01) / 1.62 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

57894-800-01 1 VIAL, SINGLE-DOSE in 1 BOX (57894-800-01) / 1.62 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

nipocalimab (185 mg/mL)

Linked Drug Pages (1)

IMAAVY ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "347a9376-5865-d57f-e063-6394a90a4ad4", "openfda": {"unii": ["87M90CV8NC"], "rxcui": ["2712699", "2712706", "2712708", "2712709"], "spl_set_id": ["8886274c-f2b2-48af-85c1-2f90bfe304b8"], "manufacturer_name": ["Janssen Biotech, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 BOX (57894-800-01)  / 1.62 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "57894-800-01", "marketing_start_date": "20250429"}], "brand_name": "IMAAVY", "product_id": "57894-800_347a9376-5865-d57f-e063-6394a90a4ad4", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "product_ndc": "57894-800", "generic_name": "nipocalimab", "labeler_name": "Janssen Biotech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "IMAAVY", "active_ingredients": [{"name": "NIPOCALIMAB", "strength": "185 mg/mL"}], "application_number": "BLA761430", "marketing_category": "BLA", "marketing_start_date": "20250429", "listing_expiration_date": "20261231"}