FDA.reportPublic FDA data

Daptomycin

Product NDC
70511-182
11-digit product format
705110182
Labeler code
70511
Product ID
70511-182_2be7556c-17a9-47ff-82bd-0b1b3316b6a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Daptomycin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
MAIA Pharmaceuticals, Inc.
Application
NDA217630
Marketing category
NDA
Marketing start
2025-09-08
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, 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
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70511-182-15Daptomycin1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,13
70511-182-84Daptomycin10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70511-182DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MAIA PHARMACEUTICALS, INC.]2Current NDC, 2 package rows20250402_d87bd6b5-bf92-49c1-879b-dc2add3deae6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1996246DAPTOmycin 350 MG InjectionPSNd87bd6b5-bf92-49c1-879b-dc2add3deae63
403920DAPTOmycin 500 MG InjectionPSNd87bd6b5-bf92-49c1-879b-dc2add3deae63
1996246daptomycin 350 MG InjectionSCDd87bd6b5-bf92-49c1-879b-dc2add3deae63
403920daptomycin 500 MG InjectionSCDd87bd6b5-bf92-49c1-879b-dc2add3deae63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70511-182-15705110182151 in 1 VIAL, SINGLE-DOSEHistorical
70511-182-847051101828410 VIAL, SINGLE-DOSE in 1 CARTON (70511-182-84) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (70511-182-15) 2025-09-08NoNoCurrent