Plerixafor

Product NDC
43598-308
11-digit product format
435980308
Labeler code
43598
Product ID
43598-308_1df6ec0d-0508-29af-33c2-3a9d19a040df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Plerixafor
Dosage form
SOLUTION
Route
SUBCUTANEOUS
Labeler
Dr. Reddy's Laboratories Inc
Application
ANDA205182
Marketing category
ANDA
Marketing start
2023-11-06
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
43598-308-23Plerixafor1.2 mL in 1 VIAL, SINGLE-DOSESOLUTION1.211
43598-308-23Plerixafor1 in 1 CARTONSOLUTION111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-308-23ML - Milliliter43598-308f35cef12-9c5d-41c2-94fa-b0d1e048a50f12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-308PLERIXAFOR SOLUTION [DR. REDDY'S LABORATORIES INC]11Current NDC, 2 package rows20240629_58c9fa02-3701-d411-f946-790a62ddc064.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828700plerixafor 24 MG in 1.2 ML InjectionPSN58c9fa02-3701-d411-f946-790a62ddc06411
8287001.2 ML plerixafor 20 MG/ML InjectionSCD58c9fa02-3701-d411-f946-790a62ddc06411
828700plerixafor 24 MG per 1.2 ML InjectionSY58c9fa02-3701-d411-f946-790a62ddc06411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
43598-308-23435980308231 VIAL, SINGLE-DOSE in 1 CARTON (43598-308-23) / 1.2 mL in 1 VIAL, SINGLE-DOSE2023-11-06NoNoHistorical