Home NDC 45963-609 Fludarabine phosphate
Product NDC 45963-609
11-digit product format 459630609
Labeler code 45963
Product ID 45963-609_6ee71a09-01b9-4412-9048-a8ed9b6b0051
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fludarabine phosphate
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Actavis Pharma, Inc.
Application ANDA078610
Marketing category ANDA
Marketing start 2015-01-05
Substance FLUDARABINE PHOSPHATE
Active strength 50 mg/2mL
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 A078610-001 FLUDARABINE PHOSPHATE FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP RS 2009-02-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078610-001 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 · 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 A078610-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP RS 2009-02-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078610-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP RS 2009-02-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078610-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP RS 2009-02-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078610-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP RS 2009-02-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078610-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP RS 2009-02-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078610-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP RS 2009-02-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078610-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP RS 2009-02-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078610-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP RS 2009-02-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078610-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP RS 2009-02-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078610-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP RS 2009-02-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078610-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP RS 2009-02-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078610-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP RS 2009-02-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078610-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP RS 2009-02-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078610-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP RS 2009-02-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078610-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP RS 2009-02-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078610-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP RS 2009-02-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078610-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP RS 2009-02-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078610-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP 2009-02-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078610-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP RS 2009-02-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078610-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP 2009-02-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078610-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP 2009-02-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078610-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP 2009-02-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078610-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP 2009-02-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078610-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP 2009-02-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078610-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP 2009-02-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078610-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP 2009-02-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078610-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP 2009-02-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078610-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP RS 2009-02-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078610-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP RS 2009-02-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078610-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP RS 2009-02-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078610-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP RS 2009-02-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078610-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP RS 2009-02-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078610-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP RS 2009-02-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078610-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP RS 2009-02-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078610-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP RS 2009-02-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078610-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP RS 2009-02-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078610-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP RS 2009-02-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078610-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP RS 2009-02-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078610-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP RS 2009-02-11 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078610-001 FLUDARABINE PHOSPHATE 50MG/VIAL INJECTABLE / INJECTION AP RS 2009-02-11 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 50 mg/2mL
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 1740864 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 45963-609-55 Fludarabine phosphate 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 12 45963-609-55 Fludarabine phosphate 2 mL in 1 VIAL, GLASS INJECTION, POWDER, LYOPHILIZED, 2 12
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FLUDARABINE PHOSPHATE ACTIVE INGREDIENT 1X9VK9O1SC FLUDARABINE PHOSPHATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTAVIS PHARMA, INC.] 8 FLUDARABINE ACTIVE MOIETY P2K93U8740 FLUDARABINE PHOSPHATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTAVIS PHARMA, INC.] 8 MANNITOL INACTIVE INGREDIENT 3OWL53L36A FLUDARABINE PHOSPHATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTAVIS PHARMA, INC.] 8 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I FLUDARABINE PHOSPHATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTAVIS PHARMA, INC.] 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 45963-609 FLUDARABINE PHOSPHATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTAVIS PHARMA, INC.] 12 Current NDC, Legacy NDC, 2 package rows 20240403_3adca34b-4f65-4e21-8058-3c01fc7fc9bb.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 45963-609-55 45963060955 1 VIAL, GLASS in 1 CARTON (45963-609-55) / 2 mL in 1 VIAL, GLASS 2015-01-05 0000-00-00 No No Current