FDA.reportPublic FDA data

fludarabine phosphate

Product NDC
24201-237
11-digit product format
242010237
Labeler code
24201
Product ID
24201-237_f1ed1d03-2d86-90da-e053-2a95a90a8c4d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fludarabine phosphate
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc. (dba Leucadia Pharmaceuticals)
Application
ANDA076349
Marketing category
ANDA
Marketing start
2017-12-13
Marketing end
0000-00-00
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
2024-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct24201-237DDiscontinued by firm2026-07-31
excluded packagepackage24201-23724201-237-01DDiscontinued by firm2026-07-31

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
A076349-001FLUDARABINE PHOSPHATEFLUDARABINE PHOSPHATE50MG/VIALINJECTABLE / INJECTIONAP2003-08-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076349-001AP

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 22:54:322026-06A076349-001FLUDARABINE PHOSPHATE50MG/VIALINJECTABLE / INJECTIONAP2003-08-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A076349-001AP1a50c72e98297…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
24201-237-012023-10-23C16284748780-10191ceaa-6ce2-198a-e063-dbdaa90aec3eFludarabine Phosphate for Injection, USP (For Intravenous Use Only)
24201-237-012023-07-28C16284748780-10191ceaa-6ce2-198a-e063-dbdaa90aec3eFludarabine Phosphate for Injection, USP (For Intravenous Use Only)

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24201-237-01EA - Each24201-237caa4c5f6-61c0-430e-81ee-e8afd3ff396012018-02-20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24201-237-01242010237011 VIAL in 1 CARTON (24201-237-01) > 2 mL in 1 VIAL1 vial2017-12-130000-00-00NoNoCurrent