Daptomycin

Product NDC
45932-0039
11-digit product format
459320039
Labeler code
45932
Product ID
45932-0039_124c90b9-3a96-4e66-9818-8088cd70cd86
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Daptomycin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Xellia Pharmaceuticals USA, LLC
Application
NDA209949
Marketing category
NDA
Marketing start
2018-07-19
Marketing end
0000-00-00
Substance
DAPTOMYCIN
Active strength
350 mg/7mL
Pharmacologic classes
Lipopeptide Antibacterial [EPC],Lipopeptides [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
45ca3ac7-6ee8-4e99-92a6-dc0b401e151aProduct name120250724
223d8260-7a4e-4ebd-9635-845422d6a8adProduct name920240909
ca803a62-3799-476f-bbc6-024f77cb0320Product name420240207
cad85d83-8fb9-49f8-a5a6-a399af412964Product name120230922
8e59a5ed-f224-4156-b534-1ae4d0b6dfd7Product name120230721
ea2c89ab-e8f8-425f-9693-c923fa1e1703Product name120220929

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45932-0039-1Daptomycin1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,19
45932-0039-1Daptomycin7 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,79

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45932-0039DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [XELLIA PHARMACEUTICALS USA, LLC]9Legacy NDC, 2 package rows20191007_e3e6b91e-c673-46da-a654-2bb1312cb02b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1996246DAPTOmycin 350 MG InjectionPSNe3e6b91e-c673-46da-a654-2bb1312cb02b9
1996246daptomycin 350 MG InjectionSCDe3e6b91e-c673-46da-a654-2bb1312cb02b9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
45932-0039-1459320039011 in 1 CARTONHistorical