FDA.reportPublic FDA data

daptomycin

Product NDC
83090-011
11-digit product format
830900011
Labeler code
83090
Product ID
83090-011_5ef48d1a-eecc-4782-b347-7930a733e603
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
daptomycin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
Route
INTRAVENOUS
Labeler
Sintetica US LLC
Application
ANDA215890
Marketing category
ANDA
Marketing start
2023-11-05
Substance
DAPTOMYCIN
Active strength
500 mg/20mL
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/20mL

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83090-011-012025-02-07C16284748780-12cef2736-7b67-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use DAPTOMYCIN FOR INJECTION safely and effectively. See full prescribing information for DAPTOMYCIN FOR INJECTION. DAPTOMYCIN for lnjection, tor lntravenous Use Initial U.S. Approval: 2003
83090-011-012025-01-30C16284748780-12cef2736-7b67-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use DAPTOMYCIN FOR INJECTION safely and effectively. See full prescribing information for DAPTOMYCIN FOR INJECTION. DAPTOMYCIN for lnjection, tor lntravenous Use Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83090-011-01daptomycin1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,12
83090-011-01daptomycin10 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83090-011-01EA - Each83090-0113b3c3f01-7035-400d-b65e-eb5d920b907612024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83090-011DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION [SINTETICA US LLC]2Current NDC, 2 package rows20250210_0e55bfa7-7dbf-4fa1-8aee-eac3fe4e05e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403920DAPTOmycin 500 MG InjectionPSN0e55bfa7-7dbf-4fa1-8aee-eac3fe4e05e32
403920daptomycin 500 MG InjectionSCD0e55bfa7-7dbf-4fa1-8aee-eac3fe4e05e32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83090-011-01830900011011 VIAL, SINGLE-DOSE in 1 CARTON (83090-011-01) / 10 mL in 1 VIAL, SINGLE-DOSE2023-11-05NoNoCurrent