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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090724-001FLUDARABINE PHOSPHATEFLUDARABINE PHOSPHATE50MG/2ML (25MG/ML)INJECTABLE / INJECTIONAP12010-09-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A090724-001AP1

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A090724-001FLUDARABINE PHOSPHATE50MG/2ML (25MG/ML)INJECTABLE / INJECTIONAP12010-09-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A090724-001AP11a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fludarabine PhosphateFLUDARABINE PHOSPHATEAreva Pharmaceuticals8039c2e3-ffe5-3997-e053-2991aa0ad9d02023-02-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090724
application number: ANDA090724
ndc (product): 59923-604
Fludarabine PhosphateFLUDARABINE PHOSPHATELannett Company, Inc.0170c0f4-d502-4f8f-bdbf-6439f3ed33fb2023-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090724
application number: ANDA090724

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1X9VK9O1SCInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1740865Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8039c2e3-ffe5-3997-e053-2991aa0ad9d0Available on FDA.report

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