IXEMPRA

Product NDC
70020-1911
11-digit product format
700201911
Labeler code
70020
Product ID
70020-1911_452ab301-102b-ac80-e063-6394a90ab113
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ixabepilone
Dosage form
KIT
Route
INTRAVENOUS
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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70020-1911-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70020-1911-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70020-1911-10efc9e666f02…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022065-001IXEMPRA KITIXABEPILONE15MG/VIALINJECTABLE / INTRAVENOUSRLD, RS2007-10-16
N022065-002IXEMPRA KITIXABEPILONE45MG/VIALINJECTABLE / INTRAVENOUSRLD, RS2007-10-16

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N022065-001IXEMPRA KIT15MG/VIALINJECTABLE / INTRAVENOUSRLD, RS2007-10-1684e616aacf4f…
2026-09-14 22:38:342026-08N022065-002IXEMPRA KIT45MG/VIALINJECTABLE / INTRAVENOUSRLD, RS2007-10-1684e616aacf4f…
2026-08-18 06:07:402026-07N022065-001IXEMPRA KIT15MG/VIALINJECTABLE / INTRAVENOUSRLD, RS2007-10-16caaa826d4ba7…
2026-08-18 06:07:402026-07N022065-002IXEMPRA KIT45MG/VIALINJECTABLE / INTRAVENOUSRLD, RS2007-10-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022065-001IXEMPRA KIT15MG/VIALINJECTABLE / INTRAVENOUSRLD, RS2007-10-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022065-002IXEMPRA KIT45MG/VIALINJECTABLE / INTRAVENOUSRLD, RS2007-10-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022065-001IXEMPRA KIT15MG/VIALINJECTABLE / INTRAVENOUSRLD, RS2007-10-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022065-002IXEMPRA KIT45MG/VIALINJECTABLE / INTRAVENOUSRLD, RS2007-10-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08N022065-001IXEMPRA KIT15MG/VIALINJECTABLE / INTRAVENOUSRLD, RS2007-10-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022065-002IXEMPRA KIT45MG/VIALINJECTABLE / INTRAVENOUSRLD, RS2007-10-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022065-001IXEMPRA KIT15MG/VIALINJECTABLE / INTRAVENOUSRLD, RS2007-10-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022065-002IXEMPRA KIT45MG/VIALINJECTABLE / INTRAVENOUSRLD, RS2007-10-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022065-001IXEMPRA KIT15MG/VIALINJECTABLE / INTRAVENOUSRLD, RS2007-10-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022065-002IXEMPRA KIT45MG/VIALINJECTABLE / INTRAVENOUSRLD, RS2007-10-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022065-001IXEMPRA KIT15MG/VIALINJECTABLE / INTRAVENOUSRLD, RS2007-10-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022065-002IXEMPRA KIT45MG/VIALINJECTABLE / INTRAVENOUSRLD, RS2007-10-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022065-001IXEMPRA KIT15MG/VIALINJECTABLE / INTRAVENOUSRLD, RS2007-10-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022065-002IXEMPRA KIT45MG/VIALINJECTABLE / INTRAVENOUSRLD, RS2007-10-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022065-001IXEMPRA KIT15MG/VIALINJECTABLE / INTRAVENOUSRLD, RS2007-10-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022065-002IXEMPRA KIT45MG/VIALINJECTABLE / INTRAVENOUSRLD, RS2007-10-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022065-001IXEMPRA KIT15MG/VIALINJECTABLE / INTRAVENOUSRLD, RS2007-10-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022065-002IXEMPRA KIT45MG/VIALINJECTABLE / INTRAVENOUSRLD, RS2007-10-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022065-001IXEMPRA KIT15MG/VIALINJECTABLE / INTRAVENOUSRLD, RS2007-10-16d06236e962d9…
2024-10-29 15:01 UTC2024-10N022065-002IXEMPRA KIT45MG/VIALINJECTABLE / INTRAVENOUSRLD, RS2007-10-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022065-001IXEMPRA KIT15MG/VIALINJECTABLE / INTRAVENOUSRLD, RS2007-10-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022065-002IXEMPRA KIT45MG/VIALINJECTABLE / INTRAVENOUSRLD, RS2007-10-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022065-001IXEMPRA KIT15MG/VIALINJECTABLE / INTRAVENOUSRLD, RS2007-10-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022065-002IXEMPRA KIT45MG/VIALINJECTABLE / INTRAVENOUSRLD, RS2007-10-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022065-001IXEMPRA KIT15MG/VIALINJECTABLE / INTRAVENOUSRLD, RS2007-10-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022065-002IXEMPRA KIT45MG/VIALINJECTABLE / INTRAVENOUSRLD, RS2007-10-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022065-001IXEMPRA KIT15MG/VIALINJECTABLE / INTRAVENOUSRLD, RS2007-10-168072bd15b7f6…
2024-05-31 18:47 UTC2024-05N022065-002IXEMPRA KIT45MG/VIALINJECTABLE / INTRAVENOUSRLD, RS2007-10-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022065-001IXEMPRA KIT15MG/VIALINJECTABLE / INTRAVENOUSRLD, RS2007-10-165c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022065-002IXEMPRA KIT45MG/VIALINJECTABLE / INTRAVENOUSRLD, RS2007-10-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022065-001IXEMPRA KIT15MG/VIALINJECTABLE / INTRAVENOUSRLD, RS2007-10-165d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022065-002IXEMPRA KIT45MG/VIALINJECTABLE / INTRAVENOUSRLD, RS2007-10-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022065-001IXEMPRA KIT15MG/VIALINJECTABLE / INTRAVENOUSRLD, RS2007-10-164b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N022065-002IXEMPRA KIT45MG/VIALINJECTABLE / INTRAVENOUSRLD, RS2007-10-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022065-001IXEMPRA KIT15MG/VIALINJECTABLE / INTRAVENOUSRLD, RS2007-10-1674a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022065-002IXEMPRA KIT45MG/VIALINJECTABLE / INTRAVENOUSRLD, RS2007-10-1674a2ff9319b5…

Observed Orange Book patent history#

Patent history page 1 of 11 · 432 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022065-00173122372024-08-21U-96531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022065-0017312237*PED2025-02-21Pediatric extension31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022065-00273122372024-08-21U-96531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022065-0027312237*PED2025-02-21Pediatric extension31067a03dcf5…
2025-08-23 18:47 UTC2025-08N022065-0017312237*PED2025-02-21Pediatric extension6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022065-0027312237*PED2025-02-21Pediatric extension6a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022065-0017312237*PED2025-02-21Pediatric extensionfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022065-0027312237*PED2025-02-21Pediatric extensionfd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022065-0017312237*PED2025-02-21Pediatric extensionb8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022065-0027312237*PED2025-02-21Pediatric extensionb8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022065-00173122372024-08-21U-96503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022065-0017312237*PED2025-02-21Pediatric extension03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022065-00273122372024-08-21U-96503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022065-0027312237*PED2025-02-21Pediatric extension03ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022065-00173122372024-08-21U-9652680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022065-0017312237*PED2025-02-21Pediatric extension2680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022065-00273122372024-08-21U-9652680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022065-0027312237*PED2025-02-21Pediatric extension2680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022065-00173122372024-08-21U-9655bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022065-0017312237*PED2025-02-21Pediatric extension5bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022065-00273122372024-08-21U-9655bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022065-0027312237*PED2025-02-21Pediatric extension5bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022065-00173122372024-08-21U-965d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022065-0017312237*PED2025-02-21Pediatric extensiond8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022065-00273122372024-08-21U-965d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022065-0027312237*PED2025-02-21Pediatric extensiond8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022065-00173122372024-08-21U-965d06236e962d9…
2024-10-29 15:01 UTC2024-10N022065-0017312237*PED2025-02-21Pediatric extensiond06236e962d9…
2024-10-29 15:01 UTC2024-10N022065-00273122372024-08-21U-965d06236e962d9…
2024-10-29 15:01 UTC2024-10N022065-0027312237*PED2025-02-21Pediatric extensiond06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022065-00173122372024-08-21U-96579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022065-0017312237*PED2025-02-21Pediatric extension79d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022065-00273122372024-08-21U-96579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022065-0027312237*PED2025-02-21Pediatric extension79d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022065-00173122372024-08-21U-965301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022065-0017312237*PED2025-02-21Pediatric extension301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022065-00273122372024-08-21U-965301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022065-0027312237*PED2025-02-21Pediatric extension301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022065-00173122372024-08-21U-9651e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022065-0017312237*PED2025-02-21Pediatric extension1e350fbaab3a…

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
IdentifierFDA.report destination
1726271Internal RxNorm lookup
1726274Internal RxNorm lookup
1726276Internal RxNorm lookup
1726278Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
241f0b1e-8b95-470d-876f-bf1804daaf18Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70020-1911-1IXEMPRA1 in 1 PACKAGE, COMBINATIONKIT113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70020-1911-1EA - Each70020-1911a0f80cac-c5c9-4f81-9245-1ec9a9a7753412016-01-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70020-1911IXEMPRA (IXABEPILONE) KIT [R-PHARM US OPERATING, LLC]12Current NDC, Legacy NDC, 1 package rows20250227_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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IXEMPRAIXABEPILONER-Pharm US Operating, LLC241f0b1e-8b95-470d-876f-bf1804daaf182025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 022065
application number: NDA022065
ndc (product): 70020-1911

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1726276ixabepilone 15 MG InjectionPSN241f0b1e-8b95-470d-876f-bf1804daaf1813
1726271ixabepilone 45 MG InjectionPSN241f0b1e-8b95-470d-876f-bf1804daaf1813
1726278IXEMPRA 15 MG InjectionPSN241f0b1e-8b95-470d-876f-bf1804daaf1813
1726274IXEMPRA 45 MG InjectionPSN241f0b1e-8b95-470d-876f-bf1804daaf1813
1726278ixabepilone 15 MG Injection [IXEMPRA]SBD241f0b1e-8b95-470d-876f-bf1804daaf1813
1726274ixabepilone 45 MG Injection [IXEMPRA]SBD241f0b1e-8b95-470d-876f-bf1804daaf1813
1726276ixabepilone 15 MG InjectionSCD241f0b1e-8b95-470d-876f-bf1804daaf1813
1726271ixabepilone 45 MG InjectionSCD241f0b1e-8b95-470d-876f-bf1804daaf1813
1726278IXEMPRA 15 MG InjectionSY241f0b1e-8b95-470d-876f-bf1804daaf1813
1726274IXEMPRA 45 MG InjectionSY241f0b1e-8b95-470d-876f-bf1804daaf1813

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70020-1911-1700201911011 KIT in 1 PACKAGE, COMBINATION (70020-1911-1) * 45 mg in 1 VIAL, SINGLE-USE * 23.5 mL in 1 VIAL, SINGLE-USE1 kit2007-10-160000-00-00NoNoCurrent