L-Cysteine Hydrochloride (Page 2 of 2)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL – 10 mL Carton

L-CYSTEINE HYDROCHLORIDE
INJECTION, USP
0.5 g/10 mL (50 mg/mL)

NDC 0517-2064-25

25 x 10 mL SINGLE DOSE VIALS

FOR INTRAVENOUS USE AFTER DILUTION

Rx Only

Each mL contains: L-Cysteine Hydrochloride (Monohydrate) 50 mg, Water for Injection q.s. pH (range 1.0 — 2.5) may have been adjusted with Concentrated Hydrochloric Acid and/or Sodium Hydroxide. Sterile, nonpyrogenic.

DISCARD UNUSED PORTION. USE ONLY IF SOLUTION IS CLEAR.

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) (See USP Controlled Room Temperature). Directions for Use: See Package Insert.

AMERICAN
REGENT, INC.
SHIRLEY, NY 11967

Rev. 11/05

1923c5a9-figure-02
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – 50 mL Container

NDC 0517-2050-05

L-CYSTEINE HCl
INJECTION, USP
50 mg/mL

50 mL

STERILE DISPENSING VIAL

FOR IV USE AFTER DILUTION

Rx Only

AMERICAN
REGENT, INC.
SHIRLEY, NY 11967

1923c5a9-figure-03
(click image for full-size original)
L-CYSTEINE HYDROCHLORIDE
l-cysteine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0517-2064
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYSTEINE HYDROCHLORIDE (CYSTEINE) CYSTEINE HYDROCHLORIDE 50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
HYDROCHLORIC ACID
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0517-2064-25 25 VIAL, SINGLE-DOSE (VIAL) in 1 TRAY contains a VIAL, SINGLE-DOSE
1 10 mL in 1 VIAL, SINGLE-DOSE This package is contained within the TRAY (0517-2064-25)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 09/30/1990
L-CYSTEINE HYDROCHLORIDE
l-cysteine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0517-2050
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYSTEINE HYDROCHLORIDE (CYSTEINE) CYSTEINE HYDROCHLORIDE 50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
HYDROCHLORIC ACID
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0517-2050-05 5 VIAL, DISPENSING (VIAL) in 1 TRAY contains a VIAL, DISPENSING
1 50 mL in 1 VIAL, DISPENSING This package is contained within the TRAY (0517-2050-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 01/01/2000
Labeler — American Regent, Inc. (622781813)

Revised: 10/2011 American Regent, Inc.

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