Daptomycin

Product NDC
72572-102
11-digit product format
725720102
Labeler code
72572
Product ID
72572-102_eca0ec1b-b9f1-45f3-a805-42c5337c943f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Daptomycin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Civica, Inc.
Application
ANDA206005
Marketing category
ANDA
Marketing start
2019-08-20
Substance
DAPTOMYCIN
Active strength
500 mg/10mL
Pharmacologic classes
Lipopeptide Antibacterial [EPC], Lipopeptides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DAPTOMYCIN500 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNWQ5N31VKK
Rxcui403920

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
72572-102-01Daptomycin1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,17
72572-102-01Daptomycin10 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72572-102-01EA - Each72572-1027cdbb431-e108-4d84-af93-dd7b15d5933512019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72572-102DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CIVICA, INC.]7Current NDC, Legacy NDC, 2 package rows20231115_b1569dbe-7876-481e-bc1c-9c9dd85c4973.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403920DAPTOmycin 500 MG InjectionPSNb1569dbe-7876-481e-bc1c-9c9dd85c49737
403920daptomycin 500 MG InjectionSCDb1569dbe-7876-481e-bc1c-9c9dd85c49737

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72572-102-01725720102011 VIAL, SINGLE-USE in 1 CARTON (72572-102-01) / 10 mL in 1 VIAL, SINGLE-USE2019-08-200000-00-00NoNoCurrent