DAPZURA RT

Product NDC
60977-145
11-digit product format
609770145
Labeler code
60977
Product ID
60977-145_b5b302e0-d9e2-4032-ae95-cad85b08e130
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
daptomycin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
NDA213645
Marketing category
NDA
Marketing start
2022-01-25
Substance
DAPTOMYCIN
Active strength
500 mg/10mL
Pharmacologic classes
Lipopeptide Antibacterial [EPC], Lipopeptides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DAPZURA RT
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DAPTOMYCIN500 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNWQ5N31VKK
Rxcui403920, 2591793

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60977-145-01DAPZURA RT1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,17
60977-145-01DAPZURA RT10 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60977-145DAPZURA RT (DAPTOMYCIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BAXTER HEALTHCARE CORPORATION]6Current NDC, Legacy NDC, 2 package rows20250302_cb1283e1-35b8-425c-b338-d9ac0c7161f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403920DAPTOmycin 500 MG InjectionPSNcb1283e1-35b8-425c-b338-d9ac0c7161f87
2591793Dapzura 500 MG InjectionPSNcb1283e1-35b8-425c-b338-d9ac0c7161f87
2591793daptomycin 500 MG Injection [Dapzura]SBDcb1283e1-35b8-425c-b338-d9ac0c7161f87
403920daptomycin 500 MG InjectionSCDcb1283e1-35b8-425c-b338-d9ac0c7161f87
2591793Dapzura 500 MG InjectionSYcb1283e1-35b8-425c-b338-d9ac0c7161f87

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60977-145-01609770145011 VIAL in 1 CARTON (60977-145-01) > 10 mL in 1 VIAL1 vial2022-01-250000-00-00NoNoCurrent