Home NDC 70020-1910 IXEMPRA
Product NDC 70020-1910
11-digit product format 700201910
Labeler code 70020
Product ID 70020-1910_452ab301-102b-ac80-e063-6394a90ab113
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ixabepilone
Dosage form KIT
Labeler R-Pharm US Operating, LLC
Application NDA022065
Marketing category NDA
Marketing start 2007-10-16
NDC exclude flag No
Listing certified through 2026-12-31
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 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 70020-1910-1 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 70020-1910-1 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 70020-1910-1 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022065-001 IXEMPRA KIT IXABEPILONE 15MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 2007-10-16 N022065-002 IXEMPRA KIT IXABEPILONE 45MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 2007-10-16
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 3 · 86 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 N022065-001 IXEMPRA KIT 15MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 2007-10-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022065-002 IXEMPRA KIT 45MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 2007-10-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022065-001 IXEMPRA KIT 15MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 2007-10-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022065-002 IXEMPRA KIT 45MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 2007-10-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022065-001 IXEMPRA KIT 15MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 2007-10-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022065-002 IXEMPRA KIT 45MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 2007-10-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022065-001 IXEMPRA KIT 15MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 2007-10-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022065-002 IXEMPRA KIT 45MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 2007-10-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022065-001 IXEMPRA KIT 15MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 2007-10-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022065-002 IXEMPRA KIT 45MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 2007-10-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022065-001 IXEMPRA KIT 15MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 2007-10-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022065-002 IXEMPRA KIT 45MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 2007-10-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022065-001 IXEMPRA KIT 15MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 2007-10-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022065-002 IXEMPRA KIT 45MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 2007-10-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022065-001 IXEMPRA KIT 15MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 2007-10-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022065-002 IXEMPRA KIT 45MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 2007-10-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022065-001 IXEMPRA KIT 15MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 2007-10-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022065-002 IXEMPRA KIT 45MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 2007-10-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022065-001 IXEMPRA KIT 15MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 2007-10-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022065-002 IXEMPRA KIT 45MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 2007-10-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022065-001 IXEMPRA KIT 15MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 2007-10-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022065-002 IXEMPRA KIT 45MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 2007-10-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022065-001 IXEMPRA KIT 15MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 2007-10-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022065-002 IXEMPRA KIT 45MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 2007-10-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022065-001 IXEMPRA KIT 15MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 2007-10-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022065-002 IXEMPRA KIT 45MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 2007-10-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022065-001 IXEMPRA KIT 15MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 2007-10-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022065-002 IXEMPRA KIT 45MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 2007-10-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022065-001 IXEMPRA KIT 15MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 2007-10-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022065-002 IXEMPRA KIT 45MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 2007-10-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022065-001 IXEMPRA KIT 15MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 2007-10-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N022065-002 IXEMPRA KIT 45MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 2007-10-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022065-001 IXEMPRA KIT 15MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 2007-10-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022065-002 IXEMPRA KIT 45MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 2007-10-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022065-001 IXEMPRA KIT 15MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 2007-10-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022065-002 IXEMPRA KIT 45MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 2007-10-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022065-001 IXEMPRA KIT 15MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 2007-10-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022065-002 IXEMPRA KIT 45MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 2007-10-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022065-001 IXEMPRA KIT 15MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 2007-10-16 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022065-002 IXEMPRA KIT 45MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 2007-10-16 74a2ff9319b5…
Observed Orange Book patent history# Patent history page 1 of 11 · 432 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022065-001 7312237 2024-08-21 U-965 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022065-001 7312237*PED 2025-02-21 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022065-002 7312237 2024-08-21 U-965 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022065-002 7312237*PED 2025-02-21 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022065-001 7312237*PED 2025-02-21 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022065-002 7312237*PED 2025-02-21 Pediatric extension 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022065-001 7312237*PED 2025-02-21 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022065-002 7312237*PED 2025-02-21 Pediatric extension fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022065-001 7312237*PED 2025-02-21 Pediatric extension b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022065-002 7312237*PED 2025-02-21 Pediatric extension b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022065-001 7312237 2024-08-21 U-965 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022065-001 7312237*PED 2025-02-21 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022065-002 7312237 2024-08-21 U-965 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022065-002 7312237*PED 2025-02-21 Pediatric extension 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022065-001 7312237 2024-08-21 U-965 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022065-001 7312237*PED 2025-02-21 Pediatric extension 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022065-002 7312237 2024-08-21 U-965 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022065-002 7312237*PED 2025-02-21 Pediatric extension 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022065-001 7312237 2024-08-21 U-965 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022065-001 7312237*PED 2025-02-21 Pediatric extension 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022065-002 7312237 2024-08-21 U-965 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022065-002 7312237*PED 2025-02-21 Pediatric extension 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022065-001 7312237 2024-08-21 U-965 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022065-001 7312237*PED 2025-02-21 Pediatric extension d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022065-002 7312237 2024-08-21 U-965 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022065-002 7312237*PED 2025-02-21 Pediatric extension d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022065-001 7312237 2024-08-21 U-965 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022065-001 7312237*PED 2025-02-21 Pediatric extension d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022065-002 7312237 2024-08-21 U-965 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022065-002 7312237*PED 2025-02-21 Pediatric extension d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022065-001 7312237 2024-08-21 U-965 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022065-001 7312237*PED 2025-02-21 Pediatric extension 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022065-002 7312237 2024-08-21 U-965 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022065-002 7312237*PED 2025-02-21 Pediatric extension 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022065-001 7312237 2024-08-21 U-965 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022065-001 7312237*PED 2025-02-21 Pediatric extension 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022065-002 7312237 2024-08-21 U-965 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022065-002 7312237*PED 2025-02-21 Pediatric extension 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022065-001 7312237 2024-08-21 U-965 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022065-001 7312237*PED 2025-02-21 Pediatric extension 1e350fbaab3a…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base IXEMPRA
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1726271 Internal RxNorm lookup 1726274 Internal RxNorm lookup 1726276 Internal RxNorm lookup 1726278 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70020-1910-1 IXEMPRA 1 in 1 PACKAGE, COMBINATION KIT 1 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70020-1910 IXEMPRA (IXABEPILONE) KIT [R-PHARM US OPERATING, LLC] 12 Current NDC, Legacy NDC, 1 package rows 20250227_241f0b1e-8b95-470d-876f-bf1804daaf18.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 IXEMPRA IXABEPILONE R-Pharm US Operating, LLC 241f0b1e-8b95-470d-876f-bf1804daaf18 2025-12-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 022065 application number: NDA022065 ndc (product): 70020-1910
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 70020-1910-1 70020191001 1 KIT in 1 PACKAGE, COMBINATION (70020-1910-1) * 15 mg in 1 VIAL, SINGLE-USE * 8 mL in 1 VIAL, SINGLE-USE 1 kit 2007-10-16 0000-00-00 No No Current