FDA.reportPublic FDA data

DAPTOMYCIN

Product NDC
71288-016
11-digit product format
712880016
Labeler code
71288
Product ID
71288-016_0e94570f-f6e0-43ff-a12d-fc20e733d186
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DAPTOMYCIN
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA213623
Marketing category
ANDA
Marketing start
2021-06-29
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71288-016-15DAPTOMYCIN10 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,1010
71288-016-15DAPTOMYCIN1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,110
71288-016-95DAPTOMYCIN10 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,105
71288-016-95DAPTOMYCIN1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,15
71288-016-91DAPTOMYCIN10 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,104
71288-016-91DAPTOMYCIN1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-016-91EA - Each71288-016af3691d9-5c2e-4b92-b1c5-4016365f25e212022-10-06
71288-016-95EA - Each71288-016b7ff2c85-76f8-410f-a7d9-0365a5fc363112022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-016DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.]8Current NDC, Legacy NDC, 2 package rows20230608_7d50f20e-5e26-4cc0-ae45-830df5a46a42.zip
71288-016DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.]1Current NDC, Legacy NDC, 2 package rows20220507_f5736d54-5bc2-48c6-97c6-65f7422725f0.zip
71288-016DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.]1Current NDC, Legacy NDC, 2 package rows20220519_278ad91e-2141-4bc1-b142-a9caca65f1bf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403920DAPTOmycin 500 MG InjectionPSN7d50f20e-5e26-4cc0-ae45-830df5a46a4210
403920daptomycin 500 MG InjectionSCD7d50f20e-5e26-4cc0-ae45-830df5a46a4210
403920DAPTOmycin 500 MG InjectionPSN278ad91e-2141-4bc1-b142-a9caca65f1bf5
403920daptomycin 500 MG InjectionSCD278ad91e-2141-4bc1-b142-a9caca65f1bf5
403920DAPTOmycin 500 MG InjectionPSNf5736d54-5bc2-48c6-97c6-65f7422725f04
403920daptomycin 500 MG InjectionSCDf5736d54-5bc2-48c6-97c6-65f7422725f04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71288-016-15712880016151 VIAL, SINGLE-DOSE in 1 CARTON (71288-016-15) / 10 mL in 1 VIAL, SINGLE-DOSE2021-06-290000-00-00NoNoCurrent
71288-016-91712880016911 VIAL, SINGLE-DOSE in 1 CARTON (71288-016-91) / 10 mL in 1 VIAL, SINGLE-DOSE2021-06-290000-00-00NoNoCurrent
71288-016-95712880016951 VIAL, SINGLE-DOSE in 1 CARTON (71288-016-95) / 10 mL in 1 VIAL, SINGLE-DOSE2021-06-290000-00-00NoNoCurrent