Daptomycin

Product NDC
0143-9465
11-digit product format
001439465
Labeler code
0143
Product ID
0143-9465_68c548e7-ecd1-4f5a-8c67-2b17a00fab8e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Daptomycin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA206005
Marketing category
ANDA
Marketing start
2025-09-30
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
0143-9465-01Daptomycin10 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,103
0143-9465-01Daptomycin1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9465-01EA - Each0143-946551a3dbda-f811-4ca3-befe-e8738320354912025-11-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403920DAPTOmycin 500 MG InjectionPSN6aa6300a-f59b-4260-b021-8a02cfaeabb73
403920daptomycin 500 MG InjectionSCD6aa6300a-f59b-4260-b021-8a02cfaeabb73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0143-9465-01001439465011 VIAL, SINGLE-USE in 1 CARTON (0143-9465-01) / 10 mL in 1 VIAL, SINGLE-USE2025-09-30NoNoHistorical