Sugammadex: Package Insert and Label Information

SUGAMMADEX- sugammadex injection
Patheon Manufacturing Services LLC

PRINCIPAL DISPLAY PANEL — Shipping Label

LOT NUMBER: ??????
MFG. DATE: DD/MMM/YYYY

MERCK PRODUCT CODE: 2015541
QU: 192 UNLABELED VIALS

SUGAMMADEX INJECTION 100 mg/mL (2 mL)

PRODUCT CODE: 019153
STORE AT 2°- 30°C (36°- 86°F).

CAUTION: FOR MANUFACTURING, PROCESSING, OR REPACKING. RX ONLY

MANUFACTURED BY:
PATHEON MANUFACTURING SERVICES, LLC
GREENVILLE, NC 27834, USA

FOR:
MERCK SHARP & DOHME LLC:
A SUBSIDIARY OF MERCK & CO., INC.,
RAHWAY, NJ 07065 USA

MADE IN U.S.A.
LABEL NO: 529884

Shipping Label
(click image for full-size original)
SUGAMMADEX
sugammadex injection
Product Information
Product Type BULK INGREDIENT Item Code (Source) NHRIC:63552-003
Route of Administration NOT APPLICABLE DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sugammadex (Sugammadex) Sugammadex 200 mg in 2 mL
Inactive Ingredients
Ingredient Name Strength
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NHRIC:63552-003-01 1536 VIAL, GLASS in 1 CASE contains a VIAL, GLASS
1 2 mL in 1 VIAL, GLASS This package is contained within the CASE (63552-003-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
EXPORT ONLY 01/18/2016
Labeler — Patheon Manufacturing Services LLC (079415560)
Establishment
Name Address ID/FEI Operations
Patheon Manufacturing Services LLC 079415560 MANUFACTURE (63552-003), ANALYSIS (63552-003), PACK (63552-003)

Revised: 09/2022 Patheon Manufacturing Services LLC

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