rybrevant

Generic: amivantamab

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

Drug Facts

Product Profile

Brand Name rybrevant
Generic Name amivantamab
Labeler janssen biotech, inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

amivantamab 350 mg/1

Manufacturer
Janssen Biotech, Inc.

Identifiers & Regulatory

Product NDC 57894-501
Product ID 57894-501_48e684e3-4568-462c-8bbb-f3bbe58cbf17
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761210
Listing Expiration 2027-12-31
Marketing Start 2021-05-21

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 57894501
Hyphenated Format 57894-501

Supplemental Identifiers

RxCUI
2549734 2549739
UPC
0357894501015
UNII
0JSR7Z0NB6

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 rybrevant (source: ndc)
Generic Name amivantamab (source: ndc)
Application Number BLA761210 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 350 mg/1
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (57894-501-01) / 1 INJECTION in 1 VIAL, SINGLE-USE (57894-501-00)
source: ndc

Packages (1)

57894-501-01 1 VIAL, SINGLE-USE in 1 CARTON (57894-501-01) / 1 INJECTION in 1 VIAL, SINGLE-USE (57894-501-00)

Ingredients (1)

amivantamab (350 mg/1)

Linked Drug Pages (1)

Rybrevant ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "48e684e3-4568-462c-8bbb-f3bbe58cbf17", "openfda": {"upc": ["0357894501015"], "unii": ["0JSR7Z0NB6"], "rxcui": ["2549734", "2549739"], "spl_set_id": ["1466c070-9f97-4fa4-a955-6a6b59981fb8"], "manufacturer_name": ["Janssen Biotech, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (57894-501-01)  / 1 INJECTION in 1 VIAL, SINGLE-USE (57894-501-00)", "package_ndc": "57894-501-01", "marketing_start_date": "20210521"}], "brand_name": "Rybrevant", "product_id": "57894-501_48e684e3-4568-462c-8bbb-f3bbe58cbf17", "dosage_form": "INJECTION", "product_ndc": "57894-501", "generic_name": "Amivantamab", "labeler_name": "Janssen Biotech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rybrevant", "active_ingredients": [{"name": "AMIVANTAMAB", "strength": "350 mg/1"}], "application_number": "BLA761210", "marketing_category": "BLA", "marketing_start_date": "20210521", "listing_expiration_date": "20271231"}