Plerixafor

Product NDC
68083-155
11-digit product format
680830155
Labeler code
68083
Product ID
68083-155_db4c97b9-dee0-413d-ad28-e7190a956d0c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Plerixafor
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Gland Pharma Limited
Application
ANDA206644
Marketing category
ANDA
Marketing start
2024-05-03
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
68083-155-01Plerixafor1 in 1 CARTONINJECTION, SOLUTION16
68083-155-01Plerixafor1.2 mL in 1 VIALINJECTION, SOLUTION1.26

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-155PLERIXAFOR INJECTION, SOLUTION [GLAND PHARMA LIMITED]6Current NDC, 2 package rows20240509_fad65f5b-be13-4d3a-8df3-dace8e02708f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828700plerixafor 24 MG in 1.2 ML InjectionPSNfad65f5b-be13-4d3a-8df3-dace8e02708f6
8287001.2 ML plerixafor 20 MG/ML InjectionSCDfad65f5b-be13-4d3a-8df3-dace8e02708f6
828700plerixafor 24 MG per 1.2 ML InjectionSYfad65f5b-be13-4d3a-8df3-dace8e02708f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68083-155-01680830155011 VIAL in 1 CARTON (68083-155-01) / 1.2 mL in 1 VIAL1 vial2024-05-03NoNoCurrent