carvykti

Generic: ciltacabtagene autoleucel

Labeler: janssen biotech, inc
NDC Directory CELLULAR THERAPY BLA Inactive Finished

Drug Facts

Product Profile

Brand Name carvykti
Generic Name ciltacabtagene autoleucel
Labeler janssen biotech, inc
Dosage Form INJECTION, SUSPENSION
Routes
INTRAVENOUS
Active Ingredients

ciltacabtagene autoleucel 100000000 1/1

Manufacturer
Janssen Biotech, Inc

Identifiers & Regulatory

Product NDC 57894-111
Product ID 57894-111_414b9c80-a432-8c07-e063-6294a90abb73
Product Type CELLULAR THERAPY
Marketing Category BLA
Application Number BLA125746
Listing Expiration 2026-12-31
Marketing Start 2022-02-28

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 57894111
Hyphenated Format 57894-111

Supplemental Identifiers

RxCUI
2594780 2594786 2594789 2594792
UNII
0L1F17908Q

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 carvykti (source: ndc)
Generic Name ciltacabtagene autoleucel (source: ndc)
Application Number BLA125746 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100000000 1/1
source: ndc
Packaging
  • 1 INJECTION, SUSPENSION in 1 BAG (57894-111-01)
  • 1 INJECTION, SUSPENSION in 1 BAG (57894-111-02)
source: ndc

Packages (2)

57894-111-01 1 INJECTION, SUSPENSION in 1 BAG (57894-111-01) 57894-111-02 1 INJECTION, SUSPENSION in 1 BAG (57894-111-02)

Ingredients (1)

ciltacabtagene autoleucel (100000000 1/1)

Linked Drug Pages (1)

CARVYKTI ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "414b9c80-a432-8c07-e063-6294a90abb73", "openfda": {"unii": ["0L1F17908Q"], "rxcui": ["2594780", "2594786", "2594789", "2594792"], "spl_set_id": ["7d040b91-3fb8-41db-ba7f-60a36f06e2c2"], "manufacturer_name": ["Janssen Biotech, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 INJECTION, SUSPENSION in 1 BAG (57894-111-01)", "package_ndc": "57894-111-01", "marketing_start_date": "20220228"}, {"sample": false, "description": "1 INJECTION, SUSPENSION in 1 BAG (57894-111-02)", "package_ndc": "57894-111-02", "marketing_start_date": "20220228"}], "brand_name": "CARVYKTI", "product_id": "57894-111_414b9c80-a432-8c07-e063-6294a90abb73", "dosage_form": "INJECTION, SUSPENSION", "product_ndc": "57894-111", "generic_name": "ciltacabtagene autoleucel", "labeler_name": "Janssen Biotech, Inc", "product_type": "CELLULAR THERAPY", "brand_name_base": "CARVYKTI", "active_ingredients": [{"name": "CILTACABTAGENE AUTOLEUCEL", "strength": "100000000 1/1"}], "application_number": "BLA125746", "marketing_category": "BLA", "marketing_start_date": "20220228", "listing_expiration_date": "20261231"}