FDA.reportPublic FDA data

Daptomycin

Product NDC
68001-376
11-digit product format
680010376
Labeler code
68001
Product ID
68001-376_48bb305c-30e8-669b-e063-6294a90a132c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Daptomycin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
BluePoint Laboratories
Application
ANDA208375
Marketing category
ANDA
Marketing start
2019-05-01
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
Daptomycin
Listing expiration
2027-12-31

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
68001-376-68Daptomycin1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,111
68001-376-68Daptomycin10 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,1011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-376-68EA - Each68001-376aa2fac8d-b1e0-4ead-8889-36470adfd2ca12019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-376DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BLUEPOINT LABORATORIES]8Current NDC, Legacy NDC, 2 package rows20241122_d6c3df37-8481-46c2-8048-199bad37c933.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403920DAPTOmycin 500 MG InjectionPSNd6c3df37-8481-46c2-8048-199bad37c93311
403920daptomycin 500 MG InjectionSCDd6c3df37-8481-46c2-8048-199bad37c93311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68001-376-68680010376681 VIAL, SINGLE-DOSE in 1 CARTON (68001-376-68) / 10 mL in 1 VIAL, SINGLE-DOSE2019-05-010000-00-00NoNoCurrent