rybrevant faspro

Generic: amivantamab and hyaluronidase-lpuj (human recombinant)

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

Drug Facts

Product Profile

Brand Name rybrevant faspro
Generic Name amivantamab and hyaluronidase-lpuj (human recombinant)
Labeler janssen biotech, inc.
Dosage Form INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

amivantamab 1600 mg/10mL, hyaluronidase (human recombinant) 20000 mg/10mL

Manufacturer
Janssen Biotech, Inc.

Identifiers & Regulatory

Product NDC 57894-510
Product ID 57894-510_e037897a-b42a-413f-8f3f-c0f5ee7b5125
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761433
Listing Expiration 2027-12-31
Marketing Start 2025-12-19

Pharmacologic Class

Established (EPC)
endoglycosidase [epc]
Chemical Structure
glycoside hydrolases [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 57894510
Hyphenated Format 57894-510

Supplemental Identifiers

RxCUI
2729297 2729304 2729306 2729307 2735796 2735797 2735803 2735804
UPC
0357894522010
UNII
0JSR7Z0NB6 743QUY4VD8
NUI
N0000175531 M0009499

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 faspro (source: ndc)
Generic Name amivantamab and hyaluronidase-lpuj (human recombinant) (source: ndc)
Application Number BLA761433 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 1600 mg/10mL
  • 20000 mg/10mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (57894-510-01) / 10 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

57894-510-01 1 VIAL, SINGLE-DOSE in 1 CARTON (57894-510-01) / 10 mL in 1 VIAL, SINGLE-DOSE

Ingredients (2)

amivantamab (1600 mg/10mL) hyaluronidase (human recombinant) (20000 mg/10mL)

Linked Drug Pages (1)

RYBREVANT FASPRO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "e037897a-b42a-413f-8f3f-c0f5ee7b5125", "openfda": {"nui": ["N0000175531", "M0009499"], "upc": ["0357894522010"], "unii": ["0JSR7Z0NB6", "743QUY4VD8"], "rxcui": ["2729297", "2729304", "2729306", "2729307", "2735796", "2735797", "2735803", "2735804"], "spl_set_id": ["9e58b045-e352-4f62-99bf-77fae1bebc69"], "pharm_class_cs": ["Glycoside Hydrolases [CS]"], "pharm_class_epc": ["Endoglycosidase [EPC]"], "manufacturer_name": ["Janssen Biotech, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (57894-510-01)  / 10 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "57894-510-01", "marketing_start_date": "20251219"}], "brand_name": "Rybrevant Faspro", "product_id": "57894-510_e037897a-b42a-413f-8f3f-c0f5ee7b5125", "dosage_form": "INJECTION", "pharm_class": ["Endoglycosidase [EPC]", "Glycoside Hydrolases [CS]"], "product_ndc": "57894-510", "generic_name": "AMIVANTAMAB and HYALURONIDASE-lpuj (HUMAN RECOMBINANT)", "labeler_name": "Janssen Biotech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rybrevant Faspro", "active_ingredients": [{"name": "AMIVANTAMAB", "strength": "1600 mg/10mL"}, {"name": "HYALURONIDASE (HUMAN RECOMBINANT)", "strength": "20000 mg/10mL"}], "application_number": "BLA761433", "marketing_category": "BLA", "marketing_start_date": "20251219", "listing_expiration_date": "20271231"}