FDA.reportPublic FDA data

Daptomycin in Sodium Chloride

Product NDC
0338-0716
11-digit product format
003380716
Labeler code
0338
Product ID
0338-0716_7b6f75eb-02dd-4906-9ee1-4c658a5e36b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Daptomycin in Sodium Chloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
NDA213645
Marketing category
NDA
Marketing start
2022-01-25
Substance
DAPTOMYCIN
Active strength
700 mg/100mL
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 in Sodium Chloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DAPTOMYCIN700 mg/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNWQ5N31VKK
Rxcui2632127, 2632130, 2632132, 2632133

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
45ca3ac7-6ee8-4e99-92a6-dc0b401e151aProduct name120250724
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
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
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0338-0716-12Daptomycin in Sodium Chloride100 mL in 1 BAGINJECTION, SOLUTION10010
0338-0716-12Daptomycin in Sodium Chloride12 in 1 CARTONINJECTION, SOLUTION1210

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-0716-12ML - Milliliter0338-0716a9a7fee8-f73b-4e35-94c5-9d441572e1eb12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-0716DAPTOMYCIN IN SODIUM CHLORIDE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]9Current NDC, 2 package rows20250508_7ed4d986-2aa9-43cd-9a8a-fbd11cb5ecef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2632127DAPTOmycin 1000 MG in 100 ML InjectionPSN7ed4d986-2aa9-43cd-9a8a-fbd11cb5ecef10
2632130DAPTOmycin 350 MG in 50 ML InjectionPSN7ed4d986-2aa9-43cd-9a8a-fbd11cb5ecef10
2632132DAPTOmycin 500 MG in 50 ML InjectionPSN7ed4d986-2aa9-43cd-9a8a-fbd11cb5ecef10
2632133DAPTOmycin 700 MG in 100 ML InjectionPSN7ed4d986-2aa9-43cd-9a8a-fbd11cb5ecef10
2632127100 ML daptomycin 10 MG/ML InjectionSCD7ed4d986-2aa9-43cd-9a8a-fbd11cb5ecef10
2632133100 ML daptomycin 7 MG/ML InjectionSCD7ed4d986-2aa9-43cd-9a8a-fbd11cb5ecef10
263213250 ML daptomycin 10 MG/ML InjectionSCD7ed4d986-2aa9-43cd-9a8a-fbd11cb5ecef10
263213050 ML daptomycin 7 MG/ML InjectionSCD7ed4d986-2aa9-43cd-9a8a-fbd11cb5ecef10
2632127daptomycin 1000 MG per 100 ML InjectionSY7ed4d986-2aa9-43cd-9a8a-fbd11cb5ecef10
2632130daptomycin 350 MG per 50 ML InjectionSY7ed4d986-2aa9-43cd-9a8a-fbd11cb5ecef10
2632132daptomycin 500 MG per 50 ML InjectionSY7ed4d986-2aa9-43cd-9a8a-fbd11cb5ecef10
2632133daptomycin 700 MG per 100 ML InjectionSY7ed4d986-2aa9-43cd-9a8a-fbd11cb5ecef10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0338-0716-120033807161212 BAG in 1 CARTON (0338-0716-12) / 100 mL in 1 BAG12 bag2023-02-27NoNoCurrent