Daptomycin

Product NDC
42023-295
11-digit product format
420230295
Labeler code
42023
Product ID
42023-295_f210e0b8-5a7e-4ba9-b4ab-ad86a4ec8bf4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Daptomycin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Par Health USA, LLC
Application
NDA217630
Marketing category
NDA
Marketing start
2025-10-27
Substance
DAPTOMYCIN
Active strength
500 mg/1
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/1

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
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42023-295-01Daptomycin1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,12
42023-295-10Daptomycin10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42023-295-01EA - Each42023-29578997fb4-325a-48aa-8599-5899ecb69f9712025-10-14
42023-295-10EA - Each42023-29502fa3ce6-c3a6-42fa-acec-bfc13584a73912025-10-14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403920DAPTOmycin 500 MG InjectionPSNc1d47001-5e0f-46a3-b220-53f46b4fd6ac2
403920daptomycin 500 MG InjectionSCDc1d47001-5e0f-46a3-b220-53f46b4fd6ac2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
42023-295-01420230295011 in 1 VIAL, SINGLE-DOSEHistorical
42023-295-104202302951010 VIAL, SINGLE-DOSE in 1 CARTON (42023-295-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (42023-295-01) 2025-10-27NoNoCurrent