reblozyl

Generic: luspatercept

Labeler: celgene corporation
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name reblozyl
Generic Name luspatercept
Labeler celgene corporation
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

luspatercept 75 mg/1

Manufacturer
Celgene Corporation

Identifiers & Regulatory

Product NDC 59572-775
Product ID 59572-775_769ec39a-61bd-4726-b14a-9594897baa67
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761136
Listing Expiration 2027-12-31
Marketing Start 2019-11-08

Pharmacologic Class

Established (EPC)
erythroid maturation agent [epc]
Physiologic Effect
increased erythroid cell production [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59572775
Hyphenated Format 59572-775

Supplemental Identifiers

UNII
AQK7UBA1LS
NUI
N0000194025 N0000009319

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 reblozyl (source: ndc)
Generic Name luspatercept (source: ndc)
Application Number BLA761136 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 75 mg/1
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (59572-775-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS
source: ndc

Packages (1)

59572-775-01 1 VIAL, GLASS in 1 CARTON (59572-775-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS

Ingredients (1)

luspatercept (75 mg/1)

Linked Drug Pages (1)

Reblozyl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "769ec39a-61bd-4726-b14a-9594897baa67", "openfda": {"nui": ["N0000194025", "N0000009319"], "unii": ["AQK7UBA1LS"], "spl_set_id": ["82f4d266-3f52-41eb-86ba-0abf3cf468e8"], "pharm_class_pe": ["Increased Erythroid Cell Production [PE]"], "pharm_class_epc": ["Erythroid Maturation Agent [EPC]"], "manufacturer_name": ["Celgene Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (59572-775-01)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS", "package_ndc": "59572-775-01", "marketing_start_date": "20191108"}], "brand_name": "Reblozyl", "product_id": "59572-775_769ec39a-61bd-4726-b14a-9594897baa67", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Erythroid Maturation Agent [EPC]", "Increased Erythroid Cell Production [PE]"], "product_ndc": "59572-775", "generic_name": "Luspatercept", "labeler_name": "Celgene Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Reblozyl", "active_ingredients": [{"name": "LUSPATERCEPT", "strength": "75 mg/1"}], "application_number": "BLA761136", "marketing_category": "BLA", "marketing_start_date": "20191108", "listing_expiration_date": "20271231"}