FDA.reportPublic FDA data

Fludarabine Phosphate

Product NDC
59923-604
11-digit product format
599230604
Labeler code
59923
Product ID
59923-604_f4b6988f-58a9-4593-e053-2a95a90afe36
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fludarabine Phosphate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Areva Pharmaceuticals
Application
ANDA090724
Marketing category
ANDA
Marketing start
2019-12-31
Substance
FLUDARABINE PHOSPHATE
Active strength
25 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
Fludarabine Phosphate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUDARABINE PHOSPHATE25 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1X9VK9O1SC
Rxcui1740865

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3dd19520-88c4-1d40-8b27-a4c1cba807d9Product name220170518

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59923-604-022023-02-15C16284748780-1f386c649-b404-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Fludarabine Phosphate safely and effectively. See full prescribing information for Fludarabine Phosphate. Fludarabine Phosphate Injection, for intravenous use only Initial U.S. Approval 1991
59923-604-022023-01-30C16284748780-1f386c649-b404-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Fludarabine Phosphate safely and effectively. See full prescribing information for Fludarabine Phosphate. Fludarabine Phosphate Injection, for intravenous use only Initial U.S. Approval 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59923-604-02Fludarabine Phosphate1 in 1 CARTONINJECTION15
59923-604-02Fludarabine Phosphate2 mL in 1 VIAL, SINGLE-DOSEINJECTION25

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59923-604FLUDARABINE PHOSPHATE INJECTION [AREVA PHARMACEUTICALS]5Current NDC, Legacy NDC, 2 package rows20230216_8039c2e3-ffe5-3997-e053-2991aa0ad9d0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1740865fludarabine phosphate 50 MG in 2 ML InjectionPSN8039c2e3-ffe5-3997-e053-2991aa0ad9d05
17408652 ML fludarabine phosphate 25 MG/ML InjectionSCD8039c2e3-ffe5-3997-e053-2991aa0ad9d05
1740865fludarabine phosphate 50 MG per 2 ML InjectionSY8039c2e3-ffe5-3997-e053-2991aa0ad9d05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59923-604-02599230604021 VIAL, SINGLE-DOSE in 1 CARTON (59923-604-02) / 2 mL in 1 VIAL, SINGLE-DOSE2019-12-310000-00-00NoNoCurrent