FDA.reportPublic FDA data

SIVEXTRO

Product NDC
72000-320
11-digit product format
720000320
Labeler code
72000
Product ID
72000-320_6b3f7c1e-f936-4651-9cfe-43f1634a00c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tedizolid phosphate
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Nabriva Therapeutics US, Inc.
Application
NDA205436
Marketing category
NDA
Marketing start
2014-06-20
Marketing end
0000-00-00
Substance
TEDIZOLID PHOSPHATE
Active strength
200 mg/4mL
Pharmacologic classes
Breast Cancer Resistance Protein Inhibitors [MoA], Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
20511d74-2137-4dc9-8a06-45c653d4b070Product name120161117
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72000-320-102024-11-21C16284748780-11030e365-65b1-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use SIVEXTRO ® safely and effectively. See full prescribing information for SIVEXTRO. SIVEXTRO ® (tedizolid phosphate) for injection, for intravenous use SIVEXTRO ® (tedizolid phosphate) tablet, for oral use Initial U.S. Approval: 2014
72000-320-102024-01-30C16284748780-11030e365-65b1-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use SIVEXTRO ® safely and effectively. See full prescribing information for SIVEXTRO. SIVEXTRO ® (tedizolid phosphate) for injection, for intravenous use SIVEXTRO ® (tedizolid phosphate) tablet, for oral use Initial U.S. Approval: 2014

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72000-320-10SIVEXTRO10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,107
72000-320-10SIVEXTRO4 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,47

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72000-320-10EA - Each72000-320a27c7fdd-7877-4932-a253-39672036786e12021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72000-320SIVEXTRO (TEDIZOLID PHOSPHATE) TABLET, FILM COATED SIVEXTRO (TEDIZOLID PHOSPHATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NABRIVA THERAPEUTICS US, INC.]7Legacy NDC, 2 package rows20241122_11d5c110-c48c-438f-9c7d-5adf99938534.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1540890Sivextro 200 MG InjectionPSN11d5c110-c48c-438f-9c7d-5adf999385347
1540868Sivextro 200 MG Oral TabletPSN11d5c110-c48c-438f-9c7d-5adf999385347
1540886tedizolid phosphate 200 MG InjectionPSN11d5c110-c48c-438f-9c7d-5adf999385347
1540862tedizolid phosphate 200 MG Oral TabletPSN11d5c110-c48c-438f-9c7d-5adf999385347
1540890tedizolid phosphate 200 MG Injection [Sivextro]SBD11d5c110-c48c-438f-9c7d-5adf999385347
1540868tedizolid phosphate 200 MG Oral Tablet [Sivextro]SBD11d5c110-c48c-438f-9c7d-5adf999385347
1540886tedizolid phosphate 200 MG InjectionSCD11d5c110-c48c-438f-9c7d-5adf999385347
1540862tedizolid phosphate 200 MG Oral TabletSCD11d5c110-c48c-438f-9c7d-5adf999385347
1540890Sivextro 200 MG InjectionSY11d5c110-c48c-438f-9c7d-5adf999385347
1540868Sivextro 200 MG Oral TabletSY11d5c110-c48c-438f-9c7d-5adf999385347

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72000-320-107200003201010 VIAL, GLASS in 1 CARTON (72000-320-10) > 4 mL in 1 VIAL, GLASS2014-06-200000-00-00NoNoCurrent