tecvayli

Generic: teclistamab

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

Drug Facts

Product Profile

Brand Name tecvayli
Generic Name teclistamab
Labeler janssen biotech, inc.
Dosage Form INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

teclistamab 10 mg/mL

Manufacturer
Janssen Biotech, Inc.

Identifiers & Regulatory

Product NDC 57894-449
Product ID 57894-449_70119e52-6655-465e-b0d8-daec0d0d9169
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761291
Listing Expiration 2027-12-31
Marketing Start 2022-10-25

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 57894449
Hyphenated Format 57894-449

Supplemental Identifiers

RxCUI
2619432 2619438 2619441 2619444
UNII
54534MX6Z9

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 tecvayli (source: ndc)
Generic Name teclistamab (source: ndc)
Application Number BLA761291 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (57894-449-01) / 3 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

57894-449-01 1 VIAL, SINGLE-DOSE in 1 CARTON (57894-449-01) / 3 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

teclistamab (10 mg/mL)

Linked Drug Pages (1)

TECVAYLI ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "70119e52-6655-465e-b0d8-daec0d0d9169", "openfda": {"unii": ["54534MX6Z9"], "rxcui": ["2619432", "2619438", "2619441", "2619444"], "spl_set_id": ["54e0f974-ccee-44ea-9254-40e9883cee1e"], "manufacturer_name": ["Janssen Biotech, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (57894-449-01)  / 3 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "57894-449-01", "marketing_start_date": "20221025"}], "brand_name": "TECVAYLI", "product_id": "57894-449_70119e52-6655-465e-b0d8-daec0d0d9169", "dosage_form": "INJECTION", "product_ndc": "57894-449", "generic_name": "teclistamab", "labeler_name": "Janssen Biotech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TECVAYLI", "active_ingredients": [{"name": "TECLISTAMAB", "strength": "10 mg/mL"}], "application_number": "BLA761291", "marketing_category": "BLA", "marketing_start_date": "20221025", "listing_expiration_date": "20271231"}