CLOFARABINE

Product NDC
72266-108
11-digit product format
722660108
Labeler code
72266
Product ID
72266-108_2b363395-43e9-3aee-e063-6294a90a4e89
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CLOFARABINE
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Fosun Pharma USA Inc.
Application
ANDA207831
Marketing category
ANDA
Marketing start
2019-08-19
Substance
CLOFARABINE
Active strength
1 mg/mL
Pharmacologic classes
Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CLOFARABINE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOFARABINE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii762RDY0Y2H
Rxcui486419

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
539f51b2-42f0-18ba-d69a-4dc0951237b7Product name720250107

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72266-108-01CLOFARABINE1 in 1 CARTONINJECTION14
72266-108-01CLOFARABINE20 mL in 1 VIAL, SINGLE-DOSEINJECTION204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72266-108-01ML - Milliliter72266-108a4a7a9b3-d60a-4d07-bc89-545e35299e6b12019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72266-108CLOFARABINE INJECTION [FOSUN PHARMA USA INC.]4Current NDC, Legacy NDC, 2 package rows20250110_e956b1e0-2829-4872-8c09-99462d60e922.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
486419clofarabine 20 MG in 20 ML InjectionPSNe956b1e0-2829-4872-8c09-99462d60e9224
48641920 ML clofarabine 1 MG/ML InjectionSCDe956b1e0-2829-4872-8c09-99462d60e9224
486419clofarabine 20 MG per 20 ML InjectionSYe956b1e0-2829-4872-8c09-99462d60e9224

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72266-108-01722660108011 VIAL, SINGLE-DOSE in 1 CARTON (72266-108-01) / 20 mL in 1 VIAL, SINGLE-DOSE2019-08-190000-00-00NoNoCurrent