Home NDC 0527-1242 Fludarabine Phosphate
Product NDC 0527-1242
11-digit product format 005271242
Labeler code 0527
Product ID 0527-1242_1b10ebb9-8a76-41c8-bf18-166e54471b0d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fludarabine Phosphate
Dosage form INJECTION
Route INTRAVENOUS
Labeler Lannett Company, Inc.
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090724-001 FLUDARABINE PHOSPHATE FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP1 2010-09-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090724-001 AP1
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 · 41 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 2026-02-19 14:30 UTC 2026-02 A090724-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP1 2010-09-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090724-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP1 2010-09-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090724-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP1 2010-09-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090724-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP1 2010-09-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090724-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP1 2010-09-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090724-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP1 2010-09-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090724-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP1 2010-09-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090724-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP1 2010-09-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090724-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP1 2010-09-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090724-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP1 2010-09-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090724-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP1 2010-09-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090724-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP1 2010-09-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090724-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP1 2010-09-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090724-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP1 2010-09-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090724-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP 2010-09-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090724-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP 2010-09-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090724-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP 2010-09-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090724-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP 2010-09-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090724-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP 2010-09-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090724-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP 2010-09-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090724-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP 2010-09-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090724-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP 2010-09-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090724-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP 2010-09-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090724-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP 2010-09-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090724-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP 2010-09-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090724-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP 2010-09-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090724-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP 2010-09-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090724-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP1 2010-09-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090724-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP1 2010-09-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090724-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP1 2010-09-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090724-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP1 2010-09-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090724-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP1 2010-09-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090724-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP1 2010-09-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090724-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP1 2010-09-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090724-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP1 2010-09-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090724-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP 2010-09-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090724-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP 2010-09-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090724-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP 2010-09-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090724-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP 2010-09-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A090724-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP 2010-09-27 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Fludarabine Phosphate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUDARABINE PHOSPHATE 25 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1X9VK9O1SC Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1740865 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0527-1242-02 Fludarabine Phosphate 1 in 1 CARTON INJECTION 1 1 0527-1242-02 Fludarabine Phosphate 2 mL in 1 VIAL, SINGLE-DOSE INJECTION 2 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0527-1242 FLUDARABINE PHOSPHATE INJECTION [LANNETT COMPANY, INC.] 1 Current NDC, 2 package rows 20230404_0170c0f4-d502-4f8f-bdbf-6439f3ed33fb.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0527-1242-02 00527124202 1 VIAL, SINGLE-DOSE in 1 CARTON (0527-1242-02) / 2 mL in 1 VIAL, SINGLE-DOSE 2019-12-31 No No Current