Home NDC 42658-024 Fludarabine Phosphate
Product NDC 42658-024
11-digit product format 426580024
Labeler code 42658
Product ID 42658-024_5b82547e-11ca-a21a-e063-6294a90a025b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fludarabine Phosphate
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Hisun Pharmaceuticals USA, Inc.
Application ANDA220196
Marketing category ANDA
Marketing start 2026-09-01
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A220196-001 FLUDARABINE PHOSPHATE FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION RS 2026-07-23
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A220196-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION RS 2026-07-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A220196-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION RS 2026-07-23 caaa826d4ba7…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Fludarabine Phosphate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUDARABINE PHOSPHATE 25 mg/mL
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 42658-024-01 42658002401 1 VIAL, SINGLE-DOSE in 1 CARTON (42658-024-01) / 2 mL in 1 VIAL, SINGLE-DOSE 2026-09-01 No No Current