Daptomycin

Product NDC
72572-158
11-digit product format
725720158
Labeler code
72572
Product ID
72572-158_e2ab4847-abf9-417b-8270-50c7dd7fd288
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
daptomycin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Civica, Inc.
Application
NDA217415
Marketing category
NDA
Marketing start
2025-11-28
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
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
72572-158-01Daptomycin1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,12
72572-158-01Daptomycin10 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72572-158-01EA - Each72572-158fdd30652-9ce3-45cd-b2f7-ac1da259573012026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403920DAPTOmycin 500 MG InjectionPSN1ae55ae0-d20f-4e15-b4dc-7e45c33f31522
403920daptomycin 500 MG InjectionSCD1ae55ae0-d20f-4e15-b4dc-7e45c33f31522

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72572-158-01725720158011 VIAL, SINGLE-USE in 1 CARTON (72572-158-01) / 10 mL in 1 VIAL, SINGLE-USE2025-11-28NoNoHistorical