NDC Code(s) : 51754-1007-1, 51754-1007-3
Packager : Exela Pharma Sciences, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ELCYSCysteine Hydrochloride INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51754-1007
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYSTEINE HYDROCHLORIDE(UNII: ZT934N0X4W)
(CYSTEINE - UNII:K848JZ4886) 		CYSTEINE10 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51754-1007-110 mL in 1 VIAL Type 0: Not a Combination Product28/05/2019
2NDC:51754-1007-3100 mL in 1 CARTON Type 0: Not a Combination Product28/05/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210660 05/28/2019

LABELER - Exela Pharma Sciences, LLC(831274399)

Establishment
Name Address ID/FEI Business Operations
Exela Pharma Sciences, LLC 831274399 MANUFACTURE(51754-1007), PACK(51754-1007), LABEL(51754-1007)

PRINCIPAL DISPLAY PANEL

Vial Label

Rx Only        NDC 51754-1007-1

ELCYS

(Cysteine Hydrochloride

Injection), USP

500 mg/10 mL (50 mg/mL)

Must Be Diluted

For Intravenous Use Only After Dilution

10 mL Single Dose Sterile Vial-

Discard Unused Portion

PRINCIPAL DISPLAY PANEL

Carton Label

NDC 51754-1007-3           Rx Only 

ELCYS

(Cysteine Hydrochloride Injection), USP

500 mg/10 mL (50 mg/mL)

Must Be Diluted. For Intravenous Use Only.

10 x 10 mL Single Dose SterileVials-

Discard Unused Portion