Home NDC 24201-237-01 fludarabine phosphate
Product NDC 24201-237
Requested package NDC 24201-237-01
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A076349-001 FLUDARABINE PHOSPHATE FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP 2003-08-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076349-001 AP
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.
Product history page 1 of 2 · 42 observed 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 2026-08-18 06:07:40 2026-07 A076349-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP 2003-08-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076349-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP 2003-08-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076349-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP 2003-08-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076349-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP 2003-08-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076349-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP 2003-08-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076349-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP 2003-08-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076349-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP 2003-08-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076349-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP 2003-08-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076349-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP 2003-08-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076349-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP 2003-08-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076349-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP 2003-08-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076349-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP 2003-08-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076349-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP 2003-08-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076349-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP 2003-08-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076349-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP 2003-08-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076349-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP 2003-08-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076349-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP 2003-08-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076349-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP 2003-08-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076349-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP 2003-08-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076349-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP 2003-08-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076349-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP 2003-08-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076349-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP 2003-08-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076349-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP 2003-08-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076349-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP 2003-08-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076349-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP 2003-08-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076349-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP 2003-08-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076349-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP 2003-08-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076349-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP 2003-08-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076349-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP 2003-08-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076349-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP 2003-08-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076349-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP 2003-08-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076349-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP 2003-08-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076349-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP 2003-08-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076349-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP 2003-08-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076349-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP 2003-08-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076349-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP 2003-08-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076349-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP 2003-08-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076349-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP 2003-08-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076349-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP 2003-08-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076349-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP 2003-08-28 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
FDA-Initiated Inactive NDC Indexing# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 24201-237-01 24201023701 1 VIAL in 1 CARTON (24201-237-01) > 2 mL in 1 VIAL 1 vial 2017-12-13 0000-00-00 No No Current