Daptomycin

Product NDC
63323-871
11-digit product format
633230871
Labeler code
63323
Product ID
63323-871_54a51227-ae83-4fec-a18b-ebadbc72fcf8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Daptomycin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA206005
Marketing category
ANDA
Marketing start
2016-06-28
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-871-15EA - Each63323-871494beb95-fb62-4b59-a460-429d0ca5035d12016-09-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-871-15633230871151 VIAL in 1 CARTON (63323-871-15) > 10 mL in 1 VIAL1 vial2016-06-280000-00-00NoNoCurrent