PLERIXAFOR

Product NDC
70771-1776
11-digit product format
707711776
Labeler code
70771
Product ID
70771-1776_41b76e97-b780-4fc8-b073-13bf155ad8a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
plerixafor
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Zydus Lifesciences Limited
Application
ANDA208980
Marketing category
ANDA
Marketing start
2023-07-28
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
70771-1776-1PLERIXAFOR1.2 mL in 1 VIAL, SINGLE-USEINJECTION1.21
70771-1776-1PLERIXAFOR1 in 1 CARTONINJECTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1776PLERIXAFOR INJECTION [ZYDUS LIFESCIENCES LIMITED]1Current NDC, 2 package rows20230728_43df348a-d7f2-4f14-8131-c916679a98eb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828700plerixafor 24 MG in 1.2 ML InjectionPSN43df348a-d7f2-4f14-8131-c916679a98eb1
8287001.2 ML plerixafor 20 MG/ML InjectionSCD43df348a-d7f2-4f14-8131-c916679a98eb1
828700plerixafor 24 MG per 1.2 ML InjectionSY43df348a-d7f2-4f14-8131-c916679a98eb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70771-1776-1707711776011 VIAL, SINGLE-USE in 1 CARTON (70771-1776-1) / 1.2 mL in 1 VIAL, SINGLE-USE2023-07-28NoNoCurrent