FDA.reportPublic FDA data

Daptomycin

Product NDC
25021-179
11-digit product format
250210179
Labeler code
25021
Product ID
25021-179_4245fbb1-e161-4c27-93b6-6afb59618099
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Daptomycin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
NDA208385
Marketing category
NDA
Marketing start
2018-01-15
Substance
DAPTOMYCIN
Active strength
350 mg/7mL
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
DAPTOMYCIN350 mg/7mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNWQ5N31VKK
Rxcui1996246

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
25021-179-15Daptomycin7 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,721
25021-179-15Daptomycin1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,121
25021-179-16Daptomycin10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,1021
25021-179-16Daptomycin7 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,721
25021-179-66Daptomycin7 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,73
25021-179-66Daptomycin1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,13
25021-179-67Daptomycin10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,103
25021-179-67Daptomycin7 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,73

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-179-15EA - Each25021-179ebe9e8a5-003f-4315-a0a9-0ba94bd539ab12018-07-03
25021-179-16EA - Each25021-17992e699ce-bbb4-46d8-b6d5-f36c398f804512018-07-03
25021-179-66EA - Each25021-179f9cdfe10-e279-4383-9581-97d9afb4c20712020-08-06
25021-179-67EA - Each25021-1796bfd9098-afcf-4242-bee6-23c85e36ca4e12020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-179DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS]21Current NDC, Legacy NDC, 4 package rows20241024_548f3559-0531-4c95-9e1d-81f81a3801f1.zip
25021-179DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS]3Current NDC, Legacy NDC, 4 package rows20230629_4a0ad110-e55e-4d3b-84f8-dd0b924fe2f6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1996246DAPTOmycin 350 MG InjectionPSN548f3559-0531-4c95-9e1d-81f81a3801f121
1996246daptomycin 350 MG InjectionSCD548f3559-0531-4c95-9e1d-81f81a3801f121
1996246DAPTOmycin 350 MG InjectionPSN4a0ad110-e55e-4d3b-84f8-dd0b924fe2f63
1996246daptomycin 350 MG InjectionSCD4a0ad110-e55e-4d3b-84f8-dd0b924fe2f63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25021-179-15250210179151 VIAL in 1 CARTON (25021-179-15) / 7 mL in 1 VIAL1 vial2018-01-150000-00-00NoNoCurrent
25021-179-162502101791610 VIAL in 1 CARTON (25021-179-16) / 7 mL in 1 VIAL10 vial2018-01-150000-00-00NoNoCurrent
25021-179-66250210179661 VIAL in 1 CARTON (25021-179-66) / 7 mL in 1 VIAL1 vial2020-02-010000-00-00NoNoCurrent
25021-179-672502101796710 VIAL in 1 CARTON (25021-179-67) / 7 mL in 1 VIAL10 vial2020-02-010000-00-00NoNoCurrent