daptomycin

Product NDC
0781-3295
11-digit product format
007813295
Labeler code
0781
Product ID
0781-3295_08bdaf5f-455d-4470-9481-0d8c47f9ac63
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
daptomycin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Sandoz Inc.
Application
ANDA212513
Marketing category
ANDA
Marketing start
2020-07-13
Marketing end
0000-00-00
Substance
DAPTOMYCIN
Active strength
500 mg/10mL
Pharmacologic classes
Lipopeptide Antibacterial [EPC],Lipopeptides [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-3295-70EA - Each0781-32954b7ef06a-c5d9-4a3a-adcb-53eeb502376d12020-08-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-3295-70007813295701 VIAL, SINGLE-DOSE in 1 CARTON (0781-3295-70) > 10 mL in 1 VIAL, SINGLE-DOSE2020-07-130000-00-00NoNoCurrent