ELCYS

Basic Information

Product Name

ELCYS

FDA Product Code

51754-1008

Regulatory Information

NDC Product Code

51754-1008

Application Number

NDA210660

Marketing Category

C73594

Effective Date

February 1, 2024

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use ELCYS safely and effectively. See full prescribing information for ELCYS.ELCYS (cysteine hydrochloride injection), for intravenous useInitial U.S. Approval: 1971

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: CNTM

HYDROCHLORIC ACID

Code: QTT17582CB

Class Code: CNTM

CYSTEINE HYDROCHLORIDE

Quantity: 50 mg in 1 mL

Code: ZT934N0X4W

Class Code: ACTIM

WATER

Code: 059QF0KO0R

Class Code: IACT

Active Moieties

CYSTEINE