Reblozyl

Product NDC
59572-775
11-digit product format
595720775
Labeler code
59572
Product ID
59572-775_769ec39a-61bd-4726-b14a-9594897baa67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Luspatercept
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
SUBCUTANEOUS
Labeler
Celgene Corporation
Application
BLA761136
Marketing category
BLA
Marketing start
2019-11-08
Substance
LUSPATERCEPT
Active strength
75 mg/1
Pharmacologic classes
Erythroid Maturation Agent [EPC], Increased Erythroid Cell Production [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Reblozyl
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LUSPATERCEPT75 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
AQK7UBA1LSInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2262906Internal RxNorm lookup
2262911Internal RxNorm lookup
2262913Internal RxNorm lookup
2262915Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
82f4d266-3f52-41eb-86ba-0abf3cf468e8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8806c94e-c3b1-4309-a2b0-0cbcdc62736eProduct name120200415

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59572-775-01Reblozyl1 in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,120
59572-775-01Reblozyl1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,120

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59572-775-01EA - Each59572-77517c0497b-22b6-45b2-8c61-b9c7874560da12019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59572-775REBLOZYL (LUSPATERCEPT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CELGENE CORPORATION]19Current NDC, Legacy NDC, 2 package rows20240530_82f4d266-3f52-41eb-86ba-0abf3cf468e8.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ReblozylLUSPATERCEPTCelgene Corporation82f4d266-3f52-41eb-86ba-0abf3cf468e82026-02-27Warnings, Adverse reactionsExact identifier
application number: BLA761136
ndc (product): 59572-775

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761136Reblozylluspatercept-aamt351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2262906luspatercept-aamt 25 MG InjectionPSN82f4d266-3f52-41eb-86ba-0abf3cf468e820
2262913luspatercept-aamt 75 MG InjectionPSN82f4d266-3f52-41eb-86ba-0abf3cf468e820
2262911Reblozyl 25 MG InjectionPSN82f4d266-3f52-41eb-86ba-0abf3cf468e820
2262915Reblozyl 75 MG InjectionPSN82f4d266-3f52-41eb-86ba-0abf3cf468e820
2262911luspatercept-aamt 25 MG Injection [Reblozyl]SBD82f4d266-3f52-41eb-86ba-0abf3cf468e820
2262915luspatercept-aamt 75 MG Injection [Reblozyl]SBD82f4d266-3f52-41eb-86ba-0abf3cf468e820
2262906luspatercept-aamt 25 MG InjectionSCD82f4d266-3f52-41eb-86ba-0abf3cf468e820
2262913luspatercept-aamt 75 MG InjectionSCD82f4d266-3f52-41eb-86ba-0abf3cf468e820
2262911Reblozyl 25 MG InjectionSY82f4d266-3f52-41eb-86ba-0abf3cf468e820
2262915Reblozyl 75 MG InjectionSY82f4d266-3f52-41eb-86ba-0abf3cf468e820

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59572-775-01595720775011 VIAL, GLASS in 1 CARTON (59572-775-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS2019-11-080000-00-00NoNoCurrent