Reblozyl

Product NDC
59572-711
11-digit product format
595720711
Labeler code
59572
Product ID
59572-711_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
25 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
LUSPATERCEPT25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiAQK7UBA1LS
Rxcui2262906, 2262911, 2262913, 2262915

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
59572-711-01Reblozyl1 in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,120
59572-711-01Reblozyl1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,120

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59572-711REBLOZYL (LUSPATERCEPT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CELGENE CORPORATION]19Current NDC, Legacy NDC, 2 package rows20240530_82f4d266-3f52-41eb-86ba-0abf3cf468e8.zip

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
59572-711-01595720711011 VIAL, GLASS in 1 CARTON (59572-711-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS2019-11-080000-00-00NoNoCurrent