Home NDC 63323-192 Fludarabine
Product NDC 63323-192
11-digit product format 633230192
Labeler code 63323
Product ID 63323-192_fc26c9ee-50de-4eff-b264-1882edd65414
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name FLUDARABINE PHOSPHATE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA078393
Marketing category ANDA
Marketing start 2007-11-16
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 A078393-001 FLUDARABINE PHOSPHATE FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP1 2007-10-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078393-001 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 A078393-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP1 2007-10-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078393-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP1 2007-10-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078393-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP1 2007-10-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078393-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP1 2007-10-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078393-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP1 2007-10-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078393-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP1 2007-10-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078393-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP1 2007-10-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078393-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP1 2007-10-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078393-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP1 2007-10-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078393-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP1 2007-10-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078393-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP1 2007-10-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078393-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP1 2007-10-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078393-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP1 2007-10-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078393-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP1 2007-10-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078393-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP RS 2007-10-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078393-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP RS 2007-10-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078393-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP RS 2007-10-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078393-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP RS 2007-10-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078393-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP RS 2007-10-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078393-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP RS 2007-10-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078393-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP RS 2007-10-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078393-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP RS 2007-10-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078393-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP RS 2007-10-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078393-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP RS 2007-10-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078393-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP RS 2007-10-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078393-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP RS 2007-10-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078393-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP RS 2007-10-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078393-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP1 2007-10-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078393-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP1 2007-10-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078393-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP1 2007-10-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078393-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP1 2007-10-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078393-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP1 2007-10-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078393-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP1 2007-10-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078393-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP1 2007-10-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078393-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP1 2007-10-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078393-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP RS 2007-10-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078393-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP RS 2007-10-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078393-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP RS 2007-10-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078393-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP RS 2007-10-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078393-001 FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) INJECTABLE / INJECTION AP RS 2007-10-15 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
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 63323-192-02 Fludarabine 2 mL in 1 VIAL INJECTION, SOLUTION 2 5 63323-192-02 Fludarabine 1 in 1 BOX INJECTION, SOLUTION 1 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FLUDARABINE PHOSPHATE ACTIVE INGREDIENT 1X9VK9O1SC FLUDARABINE (FLUDARABINE PHOSPHATE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 2 FLUDARABINE ACTIVE MOIETY P2K93U8740 FLUDARABINE (FLUDARABINE PHOSPHATE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 2 MANNITOL INACTIVE INGREDIENT 3OWL53L36A FLUDARABINE (FLUDARABINE PHOSPHATE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 2 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I FLUDARABINE (FLUDARABINE PHOSPHATE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-192 FLUDARABINE (FLUDARABINE PHOSPHATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 5 Current NDC, Legacy NDC, 2 package rows 20241019_cf5255cc-91fd-4132-973b-764dba142eae.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 Units Marketing start Marketing end Sample Exclude flag Status 63323-192-02 63323019202 1 VIAL in 1 BOX (63323-192-02) / 2 mL in 1 VIAL 1 vial 2007-11-16 0000-00-00 No No Current