Daptomycin

Product NDC
0143-9456
11-digit product format
001439456
Labeler code
0143
Product ID
0143-9456_8aa40ade-a628-428b-898c-076d94c40940
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
daptomycin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
NDA217415
Marketing category
NDA
Marketing start
2025-12-11
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9456-01Daptomycin1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,17
0143-9456-01Daptomycin7 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,77

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1996246DAPTOmycin 350 MG InjectionPSN74176769-b22e-4e41-8c56-051e15ec5fea7
403920DAPTOmycin 500 MG InjectionPSN74176769-b22e-4e41-8c56-051e15ec5fea7
1996246daptomycin 350 MG InjectionSCD74176769-b22e-4e41-8c56-051e15ec5fea7
403920daptomycin 500 MG InjectionSCD74176769-b22e-4e41-8c56-051e15ec5fea7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0143-9456-01001439456011 VIAL, SINGLE-USE in 1 CARTON (0143-9456-01) / 7 mL in 1 VIAL, SINGLE-USE2025-12-11NoNoHistorical