Home NDC 60505-6230 Paclitaxel protein-bound particles for injectable suspension (albumin-bound)
Product NDC 60505-6230
11-digit product format 605056230
Labeler code 60505
Product ID 60505-6230_7325d86b-947f-41a1-bf26-7e988fd17b2e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Paclitaxel
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
Route INTRAVENOUS
Labeler Apotex Corp.
Application NDA021660
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2022-04-01
Marketing end 0000-00-00
Substance PACLITAXEL
Active strength 100 mg/20mL
Pharmacologic classes Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product 60505-6230 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 60505-6230 60505-6230-4 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 60505-6230 60505-6230-4 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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.
DailyMed Product Concepts# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-6230 PACLITAXEL PROTEIN-BOUND PARTICLES FOR INJECTABLE SUSPENSION (ALBUMIN-BOUND) (PACLITAXEL) INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION [APOTEX CORP.] 3 Legacy NDC 20250122_0ab36ac8-0536-4677-b7d0-0d5f9561f76f.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 ABRAXANE PACLITAXEL Abraxis BioScience, LLC 24d10449-2936-4cd3-b7db-a7683db721e4 2022-10-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021660 application number: NDA021660
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 60505-6230-4 60505623004 1 VIAL, SINGLE-USE in 1 CARTON (60505-6230-4) > 20 mL in 1 VIAL, SINGLE-USE 2022-04-01 0000-00-00 No No Current