Plerixafor

Product NDC
65219-284
11-digit product format
652190284
Labeler code
65219
Product ID
65219-284_ba468eca-fb47-497b-8aed-a1576249ea6a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PLERIXAFOR
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Fresenius Kabi Usa, LLC
Application
NDA022311
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2023-06-22
Substance
PLERIXAFOR
Active strength
24 mg/1.2mL
Pharmacologic classes
Hematopoietic Stem Cell Mobilizer [EPC], Increased Hematopoietic Stem Cell Mobilization [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Plerixafor
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PLERIXAFOR24 mg/1.2mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiS915P5499N
Rxcui828700

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e9e3bcdc-866b-12bf-8547-f275901d8135Product name220240828

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65219-284-12Plerixafor1.2 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION1.212
65219-284-12Plerixafor1 in 1 CARTONINJECTION, SOLUTION112

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-284PLERIXAFOR INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]11Current NDC, 2 package rows20231012_5d670cb4-163e-498c-b5fa-c193ea9d55c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828700plerixafor 24 MG in 1.2 ML InjectionPSN5d670cb4-163e-498c-b5fa-c193ea9d55c012
8287001.2 ML plerixafor 20 MG/ML InjectionSCD5d670cb4-163e-498c-b5fa-c193ea9d55c012
828700plerixafor 24 MG per 1.2 ML InjectionSY5d670cb4-163e-498c-b5fa-c193ea9d55c012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
65219-284-12652190284121 VIAL, SINGLE-USE in 1 CARTON (65219-284-12) / 1.2 mL in 1 VIAL, SINGLE-USE2023-06-22NoNoCurrent