Daptomycin

Product NDC
0143-9455
11-digit product format
001439455
Labeler code
0143
Product ID
0143-9455_34a28940-21e7-4056-9ab8-dfac30198662
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Daptomycin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
NDA209949
Marketing category
NDA
Marketing start
2026-02-25
Substance
DAPTOMYCIN
Active strength
350 mg/7mL
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
DAPTOMYCIN350 mg/7mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNWQ5N31VKK
Rxcui1996246

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
0143-9455-01Daptomycin7 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,73
0143-9455-01Daptomycin1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9455-01EA - Each0143-9455376958be-761a-4be5-ae86-ba83b6d29ca612026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1996246DAPTOmycin 350 MG InjectionPSN23f39005-3008-4ab1-918d-b8acb001554e3
1996246daptomycin 350 MG InjectionSCD23f39005-3008-4ab1-918d-b8acb001554e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0143-9455-01001439455011 VIAL, SINGLE-USE in 1 CARTON (0143-9455-01) / 7 mL in 1 VIAL, SINGLE-USE2026-02-25NoNoCurrent