Home NDC 68817-134 ABRAXANE
Product NDC 68817-134
11-digit product format 688170134
Labeler code 68817
Product ID 68817-134_d1c7770f-7099-4ad3-84e2-20e638cb224e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Paclitaxel
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
Route INTRAVENOUS
Labeler Abraxis BioScience, LLC
Application NDA021660
Marketing category NDA
Marketing start 2005-02-10
Substance PACLITAXEL
Active strength 100 mg/20mL
Pharmacologic classes Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 N021660-001 ABRAXANE PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2005-01-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021660-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 14 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N021660-001 7758891 2026-02-21 U-1434 2013-10-02 N021660-001 8268348 2026-02-21 U-1290 2012-10-24 N021660-001 9101543 2026-02-21 U-1434 2015-08-18 N021660-001 8034375 2026-08-13 U-1290 2012-10-24 N021660-001 7758891*PED 2026-08-21 Pediatric extension N021660-001 8268348*PED 2026-08-21 Pediatric extension N021660-001 9101543*PED 2026-08-21 Pediatric extension N021660-001 8034375*PED 2027-02-13 Pediatric extension N021660-001 9393318 2032-03-04 U-1290 2016-08-22 N021660-001 9597409 2032-03-04 U-1290 2017-04-17 N021660-001 9393318*PED 2032-09-04 Pediatric extension N021660-001 9597409*PED 2032-09-04 Pediatric extension N021660-001 9511046 2034-01-12 U-1434 2016-12-29 N021660-001 9511046*PED 2034-07-12 Pediatric extension
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 N021660-001 ABRAXANE 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2005-01-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021660-001 ABRAXANE 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2005-01-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021660-001 ABRAXANE 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2005-01-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021660-001 ABRAXANE 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2005-01-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021660-001 ABRAXANE 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2005-01-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021660-001 ABRAXANE 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2005-01-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021660-001 ABRAXANE 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2005-01-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021660-001 ABRAXANE 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2005-01-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021660-001 ABRAXANE 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2005-01-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021660-001 ABRAXANE 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2005-01-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021660-001 ABRAXANE 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2005-01-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021660-001 ABRAXANE 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2005-01-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021660-001 ABRAXANE 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2005-01-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021660-001 ABRAXANE 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2005-01-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021660-001 ABRAXANE 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2005-01-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021660-001 ABRAXANE 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2005-01-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021660-001 ABRAXANE 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2005-01-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021660-001 ABRAXANE 100MG/VIAL FOR SUSPENSION / IV (INFUSION) RLD, RS 2005-01-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021660-001 ABRAXANE 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2005-01-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021660-001 ABRAXANE 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2005-01-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021660-001 ABRAXANE 100MG/VIAL FOR SUSPENSION / IV (INFUSION) RLD, RS 2005-01-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021660-001 ABRAXANE 100MG/VIAL FOR SUSPENSION / IV (INFUSION) RLD, RS 2005-01-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021660-001 ABRAXANE 100MG/VIAL FOR SUSPENSION / IV (INFUSION) RLD, RS 2005-01-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021660-001 ABRAXANE 100MG/VIAL FOR SUSPENSION / IV (INFUSION) RLD, RS 2005-01-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021660-001 ABRAXANE 100MG/VIAL FOR SUSPENSION / IV (INFUSION) RLD, RS 2005-01-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021660-001 ABRAXANE 100MG/VIAL FOR SUSPENSION / IV (INFUSION) RLD, RS 2005-01-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021660-001 ABRAXANE 100MG/VIAL FOR SUSPENSION / IV (INFUSION) RLD, RS 2005-01-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021660-001 ABRAXANE 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2005-01-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021660-001 ABRAXANE 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2005-01-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021660-001 ABRAXANE 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2005-01-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021660-001 ABRAXANE 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2005-01-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021660-001 ABRAXANE 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2005-01-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021660-001 ABRAXANE 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2005-01-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021660-001 ABRAXANE 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2005-01-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021660-001 ABRAXANE 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2005-01-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021660-001 ABRAXANE 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2005-01-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021660-001 ABRAXANE 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2005-01-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021660-001 ABRAXANE 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2005-01-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021660-001 ABRAXANE 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2005-01-07 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021660-001 ABRAXANE 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2005-01-07 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 26 · 1,021 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N021660-001 7758891 2026-02-21 U-1434 2013-10-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021660-001 8268348 2026-02-21 U-1290 2012-10-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021660-001 9101543 2026-02-21 U-1434 2015-08-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021660-001 8034375 2026-08-13 U-1290 2012-10-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021660-001 7758891*PED 2026-08-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021660-001 8268348*PED 2026-08-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021660-001 9101543*PED 2026-08-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021660-001 8034375*PED 2027-02-13 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021660-001 9393318 2032-03-04 U-1290 2016-08-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021660-001 9597409 2032-03-04 U-1290 2017-04-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021660-001 9393318*PED 2032-09-04 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021660-001 9597409*PED 2032-09-04 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021660-001 9511046 2034-01-12 U-1434 2016-12-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021660-001 9511046*PED 2034-07-12 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021660-001 7820788 2024-10-27 U-1290 Drug product 2010-11-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021660-001 7820788 2024-10-27 U-1092 Drug product 2010-11-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021660-001 7820788 2024-10-27 U-1434 Drug product 2010-11-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021660-001 7820788*PED 2025-04-27 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021660-001 7758891 2026-02-21 U-1434 2013-10-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021660-001 8268348 2026-02-21 U-1290 2012-10-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021660-001 9101543 2026-02-21 U-1434 2015-08-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021660-001 8034375 2026-08-13 U-1290 2012-10-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021660-001 7758891*PED 2026-08-21 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021660-001 8268348*PED 2026-08-21 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021660-001 9101543*PED 2026-08-21 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021660-001 8034375*PED 2027-02-13 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021660-001 9393318 2032-03-04 U-1290 2016-08-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021660-001 9597409 2032-03-04 U-1290 2017-04-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021660-001 9393318*PED 2032-09-04 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021660-001 9597409*PED 2032-09-04 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021660-001 9511046 2034-01-12 U-1434 2016-12-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021660-001 9511046*PED 2034-07-12 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021660-001 7820788*PED 2025-04-27 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021660-001 7758891 2026-02-21 U-1434 2013-10-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021660-001 8268348 2026-02-21 U-1290 2012-10-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021660-001 9101543 2026-02-21 U-1434 2015-08-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021660-001 8034375 2026-08-13 U-1290 2012-10-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021660-001 7758891*PED 2026-08-21 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021660-001 8268348*PED 2026-08-21 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021660-001 9101543*PED 2026-08-21 Pediatric extension 6a471c1ec25d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 47 observed states.
Additional Listing Data#
Finished product Yes
Brand name base ABRAXANE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PACLITAXEL 100 mg/20mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination P88XT4IS4D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 583214 Internal RxNorm lookup 583218 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 68817-134-50 ABRAXANE 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 37 68817-134-50 ABRAXANE 20 mL in 1 VIAL, SINGLE-USE INJECTION, POWDER, LYOPHILIZED, 20 37
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PACLITAXEL ACTIVE INGREDIENT P88XT4IS4D ABRAXANE (PACLITAXEL) INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION [ABRAXIS BIOSCIENCE, LLC] 24 PACLITAXEL ACTIVE MOIETY P88XT4IS4D ABRAXANE (PACLITAXEL) INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION [ABRAXIS BIOSCIENCE, LLC] 24 ALBUMIN HUMAN INACTIVE INGREDIENT ZIF514RVZR ABRAXANE (PACLITAXEL) INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION [ABRAXIS BIOSCIENCE, LLC] 24
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68817-134 ABRAXANE (PACLITAXEL) INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION [ABRAXIS BIOSCIENCE, LLC] 36 Current NDC, Legacy NDC, 2 package rows 20230628_24d10449-2936-4cd3-b7db-a7683db721e4.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 68817-134-50 68817013450 1 VIAL, SINGLE-USE in 1 CARTON (68817-134-50) / 20 mL in 1 VIAL, SINGLE-USE 2005-02-10 0000-00-00 No No Current