FDA.reportPublic FDA data

Daptomycin

Product NDC
70594-066
11-digit product format
705940066
Labeler code
70594
Product ID
70594-066_49c340b4-c825-4e34-adcf-f49be55ec2a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
daptomycin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Xellia Pharmaceuticals USA LLC
Application
NDA217415
Marketing category
NDA
Marketing start
2023-11-03
Substance
DAPTOMYCIN
Active strength
350 mg/7mL
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
DAPTOMYCIN350 mg/7mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNWQ5N31VKK
Rxcui403920, 1996246

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
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70594-066-012024-01-30C16284748780-11030e365-098c-111a-e063-dadaa90a10e2These 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 injection, for intravenous use Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70594-066-01Daptomycin1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,15
70594-066-01Daptomycin7 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,75

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70594-066-01EA - Each70594-06637620211-b3c4-4f03-b049-9f4c36de38c712023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70594-066DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [XELLIA PHARMACEUTICALS USA LLC]5Current NDC, 2 package rows20240531_5e1f739a-eb81-43d8-9a14-89f32b7e1ba1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1996246DAPTOmycin 350 MG InjectionPSN5e1f739a-eb81-43d8-9a14-89f32b7e1ba15
403920DAPTOmycin 500 MG InjectionPSN5e1f739a-eb81-43d8-9a14-89f32b7e1ba15
1996246daptomycin 350 MG InjectionSCD5e1f739a-eb81-43d8-9a14-89f32b7e1ba15
403920daptomycin 500 MG InjectionSCD5e1f739a-eb81-43d8-9a14-89f32b7e1ba15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70594-066-01705940066011 VIAL, SINGLE-USE in 1 CARTON (70594-066-01) / 7 mL in 1 VIAL, SINGLE-USE2023-11-03NoNoHistorical