Home NDC 63323-145 Floxuridine
Product NDC 63323-145
11-digit product format 633230145
Labeler code 63323
Product ID 63323-145_a329ca66-d65a-4fd0-a2d9-b8e70ce3bcf8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name FLOXURIDINE
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRA-ARTERIAL
Labeler Fresenius Kabi USA, LLC
Application ANDA075837
Marketing category ANDA
Marketing start 2001-03-15
Substance FLOXURIDINE
Active strength 500 mg/5mL
Pharmacologic classes Antimetabolite [EPC], Deoxyuridine [CS]
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 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 A075837-001 FLOXURIDINE FLOXURIDINE 500MG/VIAL INJECTABLE / INJECTION AP 2001-02-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075837-001 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 · 43 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 2026-09-14 22:38:34 2026-08 A075837-001 FLOXURIDINE 500MG/VIAL INJECTABLE / INJECTION AP 2001-02-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075837-001 FLOXURIDINE 500MG/VIAL INJECTABLE / INJECTION AP 2001-02-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075837-001 FLOXURIDINE 500MG/VIAL INJECTABLE / INJECTION AP 2001-02-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075837-001 FLOXURIDINE 500MG/VIAL INJECTABLE / INJECTION AP 2001-02-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075837-001 FLOXURIDINE 500MG/VIAL INJECTABLE / INJECTION AP 2001-02-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075837-001 FLOXURIDINE 500MG/VIAL INJECTABLE / INJECTION AP 2001-02-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075837-001 FLOXURIDINE 500MG/VIAL INJECTABLE / INJECTION AP 2001-02-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075837-001 FLOXURIDINE 500MG/VIAL INJECTABLE / INJECTION AP 2001-02-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075837-001 FLOXURIDINE 500MG/VIAL INJECTABLE / INJECTION AP 2001-02-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075837-001 FLOXURIDINE 500MG/VIAL INJECTABLE / INJECTION AP 2001-02-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075837-001 FLOXURIDINE 500MG/VIAL INJECTABLE / INJECTION AP 2001-02-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075837-001 FLOXURIDINE 500MG/VIAL INJECTABLE / INJECTION AP 2001-02-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075837-001 FLOXURIDINE 500MG/VIAL INJECTABLE / INJECTION AP 2001-02-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075837-001 FLOXURIDINE 500MG/VIAL INJECTABLE / INJECTION AP 2001-02-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075837-001 FLOXURIDINE 500MG/VIAL INJECTABLE / INJECTION AP 2001-02-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075837-001 FLOXURIDINE 500MG/VIAL INJECTABLE / INJECTION AP 2001-02-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075837-001 FLOXURIDINE 500MG/VIAL INJECTABLE / INJECTION AP 2001-02-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075837-001 FLOXURIDINE 500MG/VIAL INJECTABLE / INJECTION AP 2001-02-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075837-001 FLOXURIDINE 500MG/VIAL INJECTABLE / INJECTION AP 2001-02-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075837-001 FLOXURIDINE 500MG/VIAL INJECTABLE / INJECTION AP 2001-02-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075837-001 FLOXURIDINE 500MG/VIAL INJECTABLE / INJECTION AP 2001-02-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075837-001 FLOXURIDINE 500MG/VIAL INJECTABLE / INJECTION AP 2001-02-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075837-001 FLOXURIDINE 500MG/VIAL INJECTABLE / INJECTION AP 2001-02-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075837-001 FLOXURIDINE 500MG/VIAL INJECTABLE / INJECTION AP 2001-02-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075837-001 FLOXURIDINE 500MG/VIAL INJECTABLE / INJECTION AP 2001-02-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075837-001 FLOXURIDINE 500MG/VIAL INJECTABLE / INJECTION AP 2001-02-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075837-001 FLOXURIDINE 500MG/VIAL INJECTABLE / INJECTION AP 2001-02-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075837-001 FLOXURIDINE 500MG/VIAL INJECTABLE / INJECTION AP 2001-02-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075837-001 FLOXURIDINE 500MG/VIAL INJECTABLE / INJECTION AP 2001-02-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075837-001 FLOXURIDINE 500MG/VIAL INJECTABLE / INJECTION AP 2001-02-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075837-001 FLOXURIDINE 500MG/VIAL INJECTABLE / INJECTION AP 2001-02-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075837-001 FLOXURIDINE 500MG/VIAL INJECTABLE / INJECTION AP 2001-02-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075837-001 FLOXURIDINE 500MG/VIAL INJECTABLE / INJECTION AP 2001-02-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075837-001 FLOXURIDINE 500MG/VIAL INJECTABLE / INJECTION AP 2001-02-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075837-001 FLOXURIDINE 500MG/VIAL INJECTABLE / INJECTION AP 2001-02-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075837-001 FLOXURIDINE 500MG/VIAL INJECTABLE / INJECTION AP 2001-02-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075837-001 FLOXURIDINE 500MG/VIAL INJECTABLE / INJECTION AP 2001-02-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075837-001 FLOXURIDINE 500MG/VIAL INJECTABLE / INJECTION AP 2001-02-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075837-001 FLOXURIDINE 500MG/VIAL INJECTABLE / INJECTION AP 2001-02-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075837-001 FLOXURIDINE 500MG/VIAL INJECTABLE / INJECTION AP 2001-02-22 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
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 Floxuridine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLOXURIDINE 500 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 039LU44I5M Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310351 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 63323-145-07 Floxuridine 5 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 5 4 63323-145-07 Floxuridine 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FLOXURIDINE ACTIVE INGREDIENT 039LU44I5M FLOXURIDINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APP PHARMACEUTICALS, LLC] 1 FLOXURIDINE ACTIVE MOIETY 039LU44I5M FLOXURIDINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APP PHARMACEUTICALS, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-145 FLOXURIDINE (FLOXURIDINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 4 Current NDC, Legacy NDC, 2 package rows 20241019_c8edabc1-67cd-421b-a147-7c1f19f05b8e.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 63323-145-07 63323014507 1 VIAL in 1 CARTON (63323-145-07) / 5 mL in 1 VIAL 1 vial 2001-03-15 0000-00-00 No No Current