Daptomycin

Product NDC
0409-0122
11-digit product format
004090122
Labeler code
0409
Product ID
0409-0122_70737bda-cf0c-42f1-89bc-d47e321d2218
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DAPTOMYCIN
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
NDA210282
Marketing category
NDA
Marketing start
2021-08-02
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, 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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ea2c89ab-e8f8-425f-9693-c923fa1e1703Product name120220929
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-0122-01Daptomycin1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,16
0409-0122-01Daptomycin10 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-0122-01EA - Each0409-0122f0fcf45c-8b74-4ed9-bca8-9f1345d0fe2d12021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-0122DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]5Current NDC, Legacy NDC, 2 package rows20250417_1957b6ce-7382-4a7b-bf02-3595948d09c6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1996246DAPTOmycin 350 MG InjectionPSN1957b6ce-7382-4a7b-bf02-3595948d09c66
403920DAPTOmycin 500 MG InjectionPSN1957b6ce-7382-4a7b-bf02-3595948d09c66
1996246daptomycin 350 MG InjectionSCD1957b6ce-7382-4a7b-bf02-3595948d09c66
403920daptomycin 500 MG InjectionSCD1957b6ce-7382-4a7b-bf02-3595948d09c66

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0409-0122-01004090122011 VIAL, SINGLE-DOSE in 1 CARTON (0409-0122-01) / 10 mL in 1 VIAL, SINGLE-DOSE2021-08-020000-00-00NoNoCurrent