PLERIXAFOR

Product NDC
70710-1208
11-digit product format
707101208
Labeler code
70710
Product ID
70710-1208_6eded16b-f43d-4984-bd7c-33ca6d5e3195
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
plerixafor
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Zydus Pharmaceuticals USA Inc.
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
70710-1208-1PLERIXAFOR1.2 mL in 1 VIAL, SINGLE-USEINJECTION1.23
70710-1208-1PLERIXAFOR1 in 1 CARTONINJECTION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1208-1ML - Milliliter70710-120872423be0-7000-4876-bc87-042c600036d412023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1208PLERIXAFOR INJECTION [ZYDUS PHARMACEUTICALS USA INC.]3Current NDC, 2 package rows20241208_a0a058f9-1618-4853-9b8a-e9768ee86b39.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828700plerixafor 24 MG in 1.2 ML InjectionPSNa0a058f9-1618-4853-9b8a-e9768ee86b393
8287001.2 ML plerixafor 20 MG/ML InjectionSCDa0a058f9-1618-4853-9b8a-e9768ee86b393
828700plerixafor 24 MG per 1.2 ML InjectionSYa0a058f9-1618-4853-9b8a-e9768ee86b393

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70710-1208-1707101208011 VIAL, SINGLE-USE in 1 CARTON (70710-1208-1) / 1.2 mL in 1 VIAL, SINGLE-USE2023-07-28NoNoHistorical