FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
IXEMPRA
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui1726271, 1726274, 1726276, 1726278

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70020-1911-12025-02-25C16284748780-12cef2736-6ca2-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use IXEMPRA ® safely and effectively. See full prescribing information for IXEMPRA ® . IXEMPRA ® Kit (ixabepilone) for Injection, for intravenous infusion only Initial U.S. Approval: 2007
70020-1911-12025-01-30C16284748780-12cef2736-6ca2-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use IXEMPRA ® safely and effectively. See full prescribing information for IXEMPRA ® . IXEMPRA ® Kit (ixabepilone) for Injection, for intravenous infusion only Initial U.S. Approval: 2007

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

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