Home NDC 68727-800 DEFITELIO
Product NDC 68727-800
11-digit product format 687270800
Labeler code 68727
Product ID 68727-800_0269ad44-e351-4411-8866-d8d53e28fb74
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name defibrotide sodium
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Jazz Pharmaceuticals, Inc.
Application NDA208114
Marketing category NDA
Marketing start 2016-03-30
Substance DEFIBROTIDE SODIUM
Active strength 80 mg/mL
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 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 N208114-001 DEFITELIO DEFIBROTIDE SODIUM 200MG/2.5ML (80MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-03-30
Orange Book patents# Current patent rows page 1 of 1 · 5 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208114-001 11085043 2032-06-22 Drug product 2021-08-20 N208114-001 11236328 2032-06-22 U-3301 2022-02-17 N208114-001 11746348 2032-06-22 Drug product 2023-09-22 N208114-001 12529052 2032-06-22 Drug product 2026-02-17 N208114-001 12534722 2032-06-22 Drug product 2026-02-17
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 N208114-001 DEFITELIO 200MG/2.5ML (80MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-03-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208114-001 DEFITELIO 200MG/2.5ML (80MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-03-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208114-001 DEFITELIO 200MG/2.5ML (80MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-03-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208114-001 DEFITELIO 200MG/2.5ML (80MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-03-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208114-001 DEFITELIO 200MG/2.5ML (80MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-03-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208114-001 DEFITELIO 200MG/2.5ML (80MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-03-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208114-001 DEFITELIO 200MG/2.5ML (80MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-03-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208114-001 DEFITELIO 200MG/2.5ML (80MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-03-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208114-001 DEFITELIO 200MG/2.5ML (80MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-03-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208114-001 DEFITELIO 200MG/2.5ML (80MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-03-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208114-001 DEFITELIO 200MG/2.5ML (80MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-03-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208114-001 DEFITELIO 200MG/2.5ML (80MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-03-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208114-001 DEFITELIO 200MG/2.5ML (80MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-03-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208114-001 DEFITELIO 200MG/2.5ML (80MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-03-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208114-001 DEFITELIO 200MG/2.5ML (80MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-03-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208114-001 DEFITELIO 200MG/2.5ML (80MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-03-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208114-001 DEFITELIO 200MG/2.5ML (80MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-03-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208114-001 DEFITELIO 200MG/2.5ML (80MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-03-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208114-001 DEFITELIO 200MG/2.5ML (80MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-03-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208114-001 DEFITELIO 200MG/2.5ML (80MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-03-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208114-001 DEFITELIO 200MG/2.5ML (80MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-03-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208114-001 DEFITELIO 200MG/2.5ML (80MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-03-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208114-001 DEFITELIO 200MG/2.5ML (80MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-03-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208114-001 DEFITELIO 200MG/2.5ML (80MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-03-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208114-001 DEFITELIO 200MG/2.5ML (80MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-03-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208114-001 DEFITELIO 200MG/2.5ML (80MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-03-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208114-001 DEFITELIO 200MG/2.5ML (80MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-03-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208114-001 DEFITELIO 200MG/2.5ML (80MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-03-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208114-001 DEFITELIO 200MG/2.5ML (80MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-03-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208114-001 DEFITELIO 200MG/2.5ML (80MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-03-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208114-001 DEFITELIO 200MG/2.5ML (80MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-03-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208114-001 DEFITELIO 200MG/2.5ML (80MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-03-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208114-001 DEFITELIO 200MG/2.5ML (80MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-03-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208114-001 DEFITELIO 200MG/2.5ML (80MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-03-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208114-001 DEFITELIO 200MG/2.5ML (80MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-03-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208114-001 DEFITELIO 200MG/2.5ML (80MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-03-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208114-001 DEFITELIO 200MG/2.5ML (80MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-03-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208114-001 DEFITELIO 200MG/2.5ML (80MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-03-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208114-001 DEFITELIO 200MG/2.5ML (80MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-03-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208114-001 DEFITELIO 200MG/2.5ML (80MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-03-30 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 3 · 91 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 N208114-001 11085043 2032-06-22 Drug product 2021-08-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208114-001 11236328 2032-06-22 U-3301 2022-02-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208114-001 11746348 2032-06-22 Drug product 2023-09-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208114-001 12529052 2032-06-22 Drug product 2026-02-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208114-001 12534722 2032-06-22 Drug product 2026-02-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208114-001 11085043 2032-06-22 Drug product 2021-08-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208114-001 11236328 2032-06-22 U-3301 2022-02-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208114-001 11746348 2032-06-22 Drug product 2023-09-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208114-001 11085043 2032-06-22 Drug product 2021-08-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208114-001 11236328 2032-06-22 U-3301 2022-02-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208114-001 11746348 2032-06-22 Drug product 2023-09-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208114-001 11085043 2032-06-22 Drug product 2021-08-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208114-001 11236328 2032-06-22 U-3301 2022-02-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208114-001 11746348 2032-06-22 Drug product 2023-09-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208114-001 11085043 2032-06-22 Drug product 2021-08-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208114-001 11236328 2032-06-22 U-3301 2022-02-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208114-001 11746348 2032-06-22 Drug product 2023-09-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208114-001 11085043 2032-06-22 Drug product 2021-08-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208114-001 11236328 2032-06-22 U-3301 2022-02-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208114-001 11746348 2032-06-22 Drug product 2023-09-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208114-001 11085043 2032-06-22 Drug product 2021-08-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208114-001 11236328 2032-06-22 U-3301 2022-02-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208114-001 11746348 2032-06-22 Drug product 2023-09-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208114-001 11085043 2032-06-22 Drug product 2021-08-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208114-001 11236328 2032-06-22 U-3301 2022-02-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208114-001 11746348 2032-06-22 Drug product 2023-09-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208114-001 11085043 2032-06-22 Drug product 2021-08-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208114-001 11236328 2032-06-22 U-3301 2022-02-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208114-001 11746348 2032-06-22 Drug product 2023-09-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208114-001 11085043 2032-06-22 Drug product 2021-08-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208114-001 11236328 2032-06-22 U-3301 2022-02-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208114-001 11746348 2032-06-22 Drug product 2023-09-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208114-001 11085043 2032-06-22 Drug product 2021-08-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N208114-001 11236328 2032-06-22 U-3301 2022-02-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N208114-001 11746348 2032-06-22 Drug product 2023-09-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208114-001 11085043 2032-06-22 Drug product 2021-08-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208114-001 11236328 2032-06-22 U-3301 2022-02-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208114-001 11746348 2032-06-22 Drug product 2023-09-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208114-001 11085043 2032-06-22 Drug product 2021-08-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208114-001 11236328 2032-06-22 U-3301 2022-02-17 301d65b070ca…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base DEFITELIO
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEFIBROTIDE SODIUM 80 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L7CHH2B2J0 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1746527 Internal RxNorm lookup 1746532 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 68727-800-01 DEFITELIO 2.5 mL in 1 VIAL INJECTION, SOLUTION 2.5 8 68727-800-02 DEFITELIO 25 mL in 1 CARTON INJECTION, SOLUTION 25 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68727-800 DEFITELIO (DEFIBROTIDE SODIUM) INJECTION, SOLUTION [JAZZ PHARMACEUTICALS, INC.] 7 Current NDC, Legacy NDC, 2 package rows 20221217_2c3db989-d7ad-41ed-9ebf-698dcf6c24ec.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 68727-800-01 68727080001 2.5 mL in 1 VIAL (68727-800-01) 2.5 ml 2016-03-30 0000-00-00 No No Current 68727-800-02 68727080002 25 mL in 1 CARTON (68727-800-02) 25 ml 2016-03-30 0000-00-00 No No Current