NDC Code(s) : 63323-579-01, 63323-579-05
Packager : Fresenius Kabi USA, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

SINCALIDE sincalide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-579
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sincalide (UNII: M03GIQ7Z6P)
(Sincalide - UNII:M03GIQ7Z6P) 		Sincalide 5 ug in 5 mL
Inactive Ingredients
Ingredient Name Strength
mannitol(UNII: 3OWL53L36A)170 mg in 5 mL
arginine hydrochloride(UNII: F7LTH1E20Y)30 mg in 5 mL
lysine hydrochloride(UNII: JNJ23Q2COM)15 mg in 5 mL
potassium phosphate, dibasic(UNII: CI71S98N1Z)9 mg in 5 mL
methionine(UNII: AE28F7PNPL)4 mg in 5 mL
sodium metabisulfite(UNII: 4VON5FNS3C)0.04 mg in 5 mL
polysorbate 20(UNII: 7T1F30V5YH)0.005 ug in 5 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63323-579-0510 in 1 PACKAGE 04/01/2023
1NDC:63323-579-015 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
NDA NDA017697 04/01/2023

LABELER - Fresenius Kabi USA, LLC (608775388)

REGISTRANT - Bracco Diagnostics Inc. (849234661)

Establishment
Name Address ID/FEI Business Operations
Fresenius Kabi USA, LLC 840771732 ANALYSIS(63323-579), MANUFACTURE(63323-579)

PRINCIPAL DISPLAY PANEL

NDC 63323-579-05 Rx only

Sincalide
for Injection

5 mcg per vial

For Intravenous use

10 Single-Dose Vials
Discard Unused Portion

Principal Display Panel – Sincalide for Injection 5 mcg per vial – Tray Label

PRINCIPAL DISPLAY PANEL

NDC 63323-579-01 Rx only

Sincalide
for Injection

5 mcg per vial

For Intravenous use
Single-Dose Vial
Discard Unused Portion

Principal Display Panel – Sincalide for Injection 5 mcg per vial – Vial Label