NDC Code(s) : 63323-871-15
Packager : Fresenius Kabi USA, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DaptomycinDaptomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-871
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DAPTOMYCIN(UNII: NWQ5N31VKK)
(DAPTOMYCIN - UNII:NWQ5N31VKK) 		DAPTOMYCIN500 mg in 10 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63323-871-151 in 1 CARTON 28/06/2016
110 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206005 06/28/2016 06/30/2024

LABELER - Fresenius Kabi USA, LLC(608775388)

REGISTRANT - Xellia Pharmaceuticals ApS(305814345)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 500 mg Vial Label

NDC 63323-871-15

Daptomycin for Injection

500 mg/vial

Must be refrigerated.

For Intravenous Infusion.

Single-Dose Vial
Discard Unused Portion     Rx only

label

PRINCIPAL DISPLAY PANEL - 500 mg Vial Carton

NDC 63323-871-15

Daptomycin for Injection

500 mg/vial

Must be refrigerated.

For Intravenous Infusion.

Use 0.9% Sodium Chloride Injection for reconstitution only.

One Single-Dose Vial

Discard Unused Portion

Rx only    FRESENIUS KABI logo

label