Home NDC 68727-745 VYXEOS
Product NDC 68727-745
11-digit product format 687270745
Labeler code 68727
Product ID 68727-745_25abb1d8-f921-4aae-8240-1914cd80417a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name (daunorubicin and cytarabine) liposome
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
Route INTRAVENOUS
Labeler Jazz Pharmaceuticals, Inc.
Application NDA209401
Marketing category NDA
Marketing start 2017-08-03
Substance CYTARABINE; DAUNORUBICIN
Active strength 100; 44 mg/20mL; mg/20mL
Pharmacologic classes Anthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC], Topoisomerase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 · 10 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…
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 N209401-001 VYXEOS CYTARABINE; DAUNORUBICIN 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03
Orange Book patents# Current patent rows page 1 of 1 · 16 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N209401-001 8518437 2026-06-07 Drug product 2017-08-30 N209401-001 7850990 2027-01-23 U-3147 Drug product 2017-08-30 N209401-001 9271931 2027-01-23 Drug product 2017-08-30 N209401-001 7850990*PED 2027-07-23 Pediatric extension N209401-001 9271931*PED 2027-07-23 Pediatric extension N209401-001 8022279 2027-09-14 U-3147 Drug product 2017-08-30 N209401-001 8022279*PED 2028-03-14 Pediatric extension N209401-001 8092828 2029-04-01 U-3147 2017-08-30 N209401-001 8092828*PED 2029-10-01 Pediatric extension N209401-001 10028912 2032-10-15 U-3149 Drug product 2018-08-06 N209401-001 10028912 2032-10-15 U-3150 Drug product 2018-08-06 N209401-001 10166184 2032-10-15 U-3149 Drug product 2019-02-25 N209401-001 10835492 2032-10-15 U-3150 2020-12-08 N209401-001 10028912*PED 2033-04-15 Pediatric extension N209401-001 10166184*PED 2033-04-15 Pediatric extension N209401-001 10835492*PED 2033-04-15 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N209401-001 ODE-350 2028-03-30 N209401-001 PED 2028-09-30
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 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 11 · 433 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N209401-001 8518437 2026-06-07 Drug product 2017-08-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209401-001 7850990 2027-01-23 U-3147 Drug product 2017-08-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209401-001 9271931 2027-01-23 Drug product 2017-08-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209401-001 7850990*PED 2027-07-23 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209401-001 9271931*PED 2027-07-23 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209401-001 8022279 2027-09-14 U-3147 Drug product 2017-08-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209401-001 8022279*PED 2028-03-14 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209401-001 8092828 2029-04-01 U-3147 2017-08-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209401-001 8092828*PED 2029-10-01 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209401-001 10028912 2032-10-15 U-3150 Drug product 2018-08-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209401-001 10028912 2032-10-15 U-3149 Drug product 2018-08-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209401-001 10166184 2032-10-15 U-3149 Drug product 2019-02-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209401-001 10835492 2032-10-15 U-3150 2020-12-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209401-001 10028912*PED 2033-04-15 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209401-001 10166184*PED 2033-04-15 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209401-001 10835492*PED 2033-04-15 Pediatric extension caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209401-001 8518437 2026-06-07 Drug product 2017-08-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209401-001 7850990 2027-01-23 U-3147 Drug product 2017-08-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209401-001 9271931 2027-01-23 Drug product 2017-08-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209401-001 7850990*PED 2027-07-23 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209401-001 9271931*PED 2027-07-23 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209401-001 8022279 2027-09-14 U-3147 Drug product 2017-08-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209401-001 8022279*PED 2028-03-14 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209401-001 8092828 2029-04-01 U-3147 2017-08-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209401-001 8092828*PED 2029-10-01 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209401-001 10028912 2032-10-15 U-3150 Drug product 2018-08-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209401-001 10028912 2032-10-15 U-3149 Drug product 2018-08-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209401-001 10166184 2032-10-15 U-3149 Drug product 2019-02-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209401-001 10835492 2032-10-15 U-3150 2020-12-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209401-001 10028912*PED 2033-04-15 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209401-001 10166184*PED 2033-04-15 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209401-001 10835492*PED 2033-04-15 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209401-001 8431806 2025-04-22 U-3147 Drug product 2017-08-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209401-001 8518437 2026-06-07 Drug product 2017-08-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209401-001 7850990 2027-01-23 U-3147 Drug product 2017-08-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209401-001 9271931 2027-01-23 Drug product 2017-08-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209401-001 8022279 2027-09-14 U-3147 Drug product 2017-08-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209401-001 8092828 2029-04-01 U-3147 2017-08-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209401-001 10028912 2032-10-15 U-3150 Drug product 2018-08-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209401-001 10028912 2032-10-15 U-3149 Drug product 2018-08-06 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 101 observed states.
Additional Listing Data#
Finished product Yes
Brand name base VYXEOS
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CYTARABINE 100 mg/20mL DAUNORUBICIN 44 mg/20mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 04079A1RDZ Internal UNII lookup ZS7284E0ZP Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1942743 Internal RxNorm lookup 1942748 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 68727-745-01 2023-10-27 These highlights do not include all the information needed to use VYXEOS safely and effectively. See full prescribing information for VYXEOS. VYXEOS ® (daunorubicin and cytarabine) liposome for injection, for intravenous use Initial U.S. Approval: 2017 68727-745-02 2023-10-27 These highlights do not include all the information needed to use VYXEOS safely and effectively. See full prescribing information for VYXEOS. VYXEOS ® (daunorubicin and cytarabine) liposome for injection, for intravenous use Initial U.S. Approval: 2017 68727-745-05 2023-10-27 These highlights do not include all the information needed to use VYXEOS safely and effectively. See full prescribing information for VYXEOS. VYXEOS ® (daunorubicin and cytarabine) liposome for injection, for intravenous use Initial U.S. Approval: 2017 68727-745-01 2023-07-28 These highlights do not include all the information needed to use VYXEOS safely and effectively. See full prescribing information for VYXEOS. VYXEOS ® (daunorubicin and cytarabine) liposome for injection, for intravenous use Initial U.S. Approval: 2017 68727-745-02 2023-07-28 These highlights do not include all the information needed to use VYXEOS safely and effectively. See full prescribing information for VYXEOS. VYXEOS ® (daunorubicin and cytarabine) liposome for injection, for intravenous use Initial U.S. Approval: 2017 68727-745-05 2023-07-28 These highlights do not include all the information needed to use VYXEOS safely and effectively. See full prescribing information for VYXEOS. VYXEOS ® (daunorubicin and cytarabine) liposome for injection, for intravenous use Initial U.S. Approval: 2017 68727-745-01 2020-07-22 These highlights do not include all the information needed to use VYXEOS safely and effectively. See full prescribing information for VYXEOS. VYXEOS ® (daunorubicin and cytarabine) liposome for injection, for intravenous use Initial U.S. Approval: 2017 68727-745-02 2020-07-22 These highlights do not include all the information needed to use VYXEOS safely and effectively. See full prescribing information for VYXEOS. VYXEOS ® (daunorubicin and cytarabine) liposome for injection, for intravenous use Initial U.S. Approval: 2017 68727-745-05 2020-07-22 These highlights do not include all the information needed to use VYXEOS safely and effectively. See full prescribing information for VYXEOS. VYXEOS ® (daunorubicin and cytarabine) liposome for injection, for intravenous use Initial U.S. Approval: 2017
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68727-745-01 VYXEOS 20 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 20 14 68727-745-02 VYXEOS 40 mL in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 40 14 68727-745-05 VYXEOS 100 mL in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 100 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68727-745 VYXEOS ((DAUNORUBICIN AND CYTARABINE) LIPOSOME) INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION [JAZZ PHARMACEUTICALS, INC.] 12 Current NDC, Legacy NDC, 3 package rows 20241009_7ea701ce-e7d3-4349-a9c2-642a501d45c8.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join VYXEOS (DAUNORUBICIN AND CYTARABINE) LIPOSOME Jazz Pharmaceuticals, Inc. 7ea701ce-e7d3-4349-a9c2-642a501d45c8 2026-01-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 209401 application number: NDA209401 ndc (product): 68727-745
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 68727-745-01 68727074501 20 mL in 1 VIAL (68727-745-01) 20 ml 2017-08-03 0000-00-00 No No Current 68727-745-02 68727074502 40 mL in 1 CARTON (68727-745-02) 40 ml 2017-08-03 0000-00-00 No No Current 68727-745-05 68727074505 100 mL in 1 CARTON (68727-745-05) 100 ml 2017-08-03 0000-00-00 No No Current