Plerixafor

Product NDC
25021-416
11-digit product format
250210416
Labeler code
25021
Product ID
25021-416_69c3fb68-4dfb-43db-bc59-421e4b3dfa0c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Plerixafor
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA206644
Marketing category
ANDA
Marketing start
2024-08-01
Substance
PLERIXAFOR
Active strength
20 mg/mL
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
PLERIXAFOR20 mg/mL

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
25021-416-01Plerixafor1 in 1 CARTONINJECTION, SOLUTION11
25021-416-01Plerixafor1.2 mL in 1 VIALINJECTION, SOLUTION1.21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-416-01ML - Milliliter25021-416eb3ff3c4-fb4a-4ed9-891d-1bc0d0401eb312024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-416PLERIXAFOR INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]1Current NDC, 2 package rows20240805_711b7bf7-4385-4365-b12a-ede6c3f1ed45.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828700plerixafor 24 MG in 1.2 ML InjectionPSN711b7bf7-4385-4365-b12a-ede6c3f1ed451
8287001.2 ML plerixafor 20 MG/ML InjectionSCD711b7bf7-4385-4365-b12a-ede6c3f1ed451
828700plerixafor 24 MG per 1.2 ML InjectionSY711b7bf7-4385-4365-b12a-ede6c3f1ed451

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-416-01250210416011 VIAL in 1 CARTON (25021-416-01) / 1.2 mL in 1 VIAL1 vial2024-08-01NoNoHistorical