SIVEXTRO

Product NDC
72000-310
11-digit product format
720000310
Labeler code
72000
Product ID
72000-310_6b3f7c1e-f936-4651-9cfe-43f1634a00c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tedizolid phosphate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Nabriva Therapeutics US, Inc.
Application
NDA205435
Marketing category
NDA
Marketing start
2014-06-20
Marketing end
0000-00-00
Substance
TEDIZOLID PHOSPHATE
Active strength
200 mg/1
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72000-310-06SIVEXTRO6 in 1 BLISTER PACKTABLET, FILM COATED67
72000-310-06SIVEXTRO1 in 1 CARTONTABLET, FILM COATED17
72000-310-30SIVEXTRO30 in 1 BOTTLETABLET, FILM COATED307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72000-310-06EA - Each72000-31074d9b803-42d3-4ff7-9808-ceedd166974712021-05-05
72000-310-30EA - Each72000-310d3b7288b-0e59-486a-aa04-f7d82a3435cc12021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72000-310SIVEXTRO (TEDIZOLID PHOSPHATE) TABLET, FILM COATED SIVEXTRO (TEDIZOLID PHOSPHATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NABRIVA THERAPEUTICS US, INC.]7Legacy NDC, 3 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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72000-310-06720000310061 BLISTER PACK in 1 CARTON (72000-310-06) > 6 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2014-06-200000-00-00NoNoCurrent
72000-310-307200003103030 TABLET, FILM COATED in 1 BOTTLE (72000-310-30) 2014-06-200000-00-00NoNoCurrent