lynozyfic

Generic: linvoseltamab-gcpt

Labeler: regeneron pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name lynozyfic
Generic Name linvoseltamab-gcpt
Labeler regeneron pharmaceuticals, inc.
Dosage Form INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients

linvoseltamab 5 mg/2.5mL

Manufacturer
Regeneron Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 61755-054
Product ID 61755-054_d82c287f-a94e-4831-9991-4742cdd17348
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761400
Listing Expiration 2026-12-31
Marketing Start 2025-07-02

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61755054
Hyphenated Format 61755-054

Supplemental Identifiers

RxCUI
2719483 2719490 2719494 2719497
UNII
M3CPC50MZS

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 lynozyfic (source: ndc)
Generic Name linvoseltamab-gcpt (source: ndc)
Application Number BLA761400 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/2.5mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (61755-054-01) / 2.5 mL in 1 VIAL, SINGLE-DOSE (61755-054-00)
source: ndc

Packages (1)

61755-054-01 1 VIAL, SINGLE-DOSE in 1 CARTON (61755-054-01) / 2.5 mL in 1 VIAL, SINGLE-DOSE (61755-054-00)

Ingredients (1)

linvoseltamab (5 mg/2.5mL)

Linked Drug Pages (1)

LYNOZYFIC ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "d82c287f-a94e-4831-9991-4742cdd17348", "openfda": {"unii": ["M3CPC50MZS"], "rxcui": ["2719483", "2719490", "2719494", "2719497"], "spl_set_id": ["e9fd0739-1b3f-4b8b-824a-1f0a902384d3"], "manufacturer_name": ["Regeneron Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (61755-054-01)  / 2.5 mL in 1 VIAL, SINGLE-DOSE (61755-054-00)", "package_ndc": "61755-054-01", "marketing_start_date": "20250702"}], "brand_name": "LYNOZYFIC", "product_id": "61755-054_d82c287f-a94e-4831-9991-4742cdd17348", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "product_ndc": "61755-054", "generic_name": "linvoseltamab-gcpt", "labeler_name": "Regeneron Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LYNOZYFIC", "active_ingredients": [{"name": "LINVOSELTAMAB", "strength": "5 mg/2.5mL"}], "application_number": "BLA761400", "marketing_category": "BLA", "marketing_start_date": "20250702", "listing_expiration_date": "20261231"}