FDA.reportPublic FDA data

Fludarabine Phosphate

Product NDC
25021-242
11-digit product format
250210242
Labeler code
25021
Product ID
25021-242_ec7f6839-a01c-4b1b-b4b3-5573037706dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fludarabine Phosphate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA076661
Marketing category
ANDA
Marketing start
2016-10-15
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
3dd19520-88c4-1d40-8b27-a4c1cba807d9Product name220170518
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25021-242-02Fludarabine Phosphate1 in 1 CARTONINJECTION, SOLUTION12
25021-242-02Fludarabine Phosphate2 mL in 1 VIALINJECTION, SOLUTION22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-242-02ML - Milliliter25021-2422db570a4-1200-4618-88fc-6db8b11fa8f612017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-242FLUDARABINE PHOSPHATE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]2Current NDC, Legacy NDC, 2 package rows20230620_20e5acf0-90b7-45c8-be78-91eaf77c9ac0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1740865fludarabine phosphate 50 MG in 2 ML InjectionPSN20e5acf0-90b7-45c8-be78-91eaf77c9ac02
17408652 ML fludarabine phosphate 25 MG/ML InjectionSCD20e5acf0-90b7-45c8-be78-91eaf77c9ac02
1740865fludarabine phosphate 50 MG per 2 ML InjectionSY20e5acf0-90b7-45c8-be78-91eaf77c9ac02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25021-242-02250210242021 VIAL in 1 CARTON (25021-242-02) / 2 mL in 1 VIAL1 vial2016-10-150000-00-00NoNoCurrent