Home DailyMed bbbaa797-0f27-4b0c-ba40-682cefd753b1 National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 02:33:59 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
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 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 · 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 N021660-001 ABRAXANE 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2005-01-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021660-001 ABRAXANE 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2005-01-07 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 27 · 1,049 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N021660-001 7758891 2026-02-21 U-1434 2013-10-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021660-001 8268348 2026-02-21 U-1290 2012-10-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021660-001 9101543 2026-02-21 U-1434 2015-08-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021660-001 8034375 2026-08-13 U-1290 2012-10-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021660-001 7758891*PED 2026-08-21 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021660-001 8268348*PED 2026-08-21 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021660-001 9101543*PED 2026-08-21 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021660-001 8034375*PED 2027-02-13 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021660-001 9393318 2032-03-04 U-1290 2016-08-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021660-001 9597409 2032-03-04 U-1290 2017-04-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021660-001 9393318*PED 2032-09-04 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021660-001 9597409*PED 2032-09-04 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021660-001 9511046 2034-01-12 U-1434 2016-12-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021660-001 9511046*PED 2034-07-12 Pediatric extension 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021660-001 7758891 2026-02-21 U-1434 2013-10-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021660-001 8268348 2026-02-21 U-1290 2012-10-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021660-001 9101543 2026-02-21 U-1434 2015-08-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021660-001 8034375 2026-08-13 U-1290 2012-10-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021660-001 7758891*PED 2026-08-21 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021660-001 8268348*PED 2026-08-21 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021660-001 9101543*PED 2026-08-21 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021660-001 8034375*PED 2027-02-13 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021660-001 9393318 2032-03-04 U-1290 2016-08-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021660-001 9597409 2032-03-04 U-1290 2017-04-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021660-001 9393318*PED 2032-09-04 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021660-001 9597409*PED 2032-09-04 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021660-001 9511046 2034-01-12 U-1434 2016-12-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021660-001 9511046*PED 2034-07-12 Pediatric extension caaa826d4ba7…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…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 47 observed states.
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.