SUGAMMADEX INJECTION 100 mg/mL (2 mL)

Sugammadex by

Drug Labeling and Warnings

Sugammadex by is a Other medication manufactured, distributed, or labeled by Patheon Manufacturing Services LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUGAMMADEX- sugammadex injection 
Patheon Manufacturing Services LLC

----------

SUGAMMADEX INJECTION 100 mg/mL (2 mL)

PRINCIPAL DISPLAY PANEL - Shipping Label

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

MERCK PRODUCT CODE: 2006791
QU: 1,536 UNLABELED VIALS

SUGAMMADEX INJECTION 100 mg/mL (2 mL)

PRODUCT CODE: 011333
STORE AT 2°-30°C (36°-86°F).

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

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

FOR:
MERCK SHARP & DOHME CORP - MSD PRODUCTION
MOLENWEG 50
5342 CC OSS, THE NETHERLANDS

MADE IN U.S.A.
LABEL NO: 512043

SUGAMMADEX 
sugammadex injection

Product Information
Product Type	BULK INGREDIENT	Item Code (Source)	NDC: 63552-003
Route of Administration	NOT APPLICABLE

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sugammadex (UNII: 361LPM2T56) (Sugammadex Sodium - UNII:ERJ6X2MXV7)	Sugammadex	200 mg  in 2 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63552-003-01	1536 in 1 CASE	01/18/2016
1		2 mL in 1 VIAL, GLASS

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	Business Operations
Patheon Manufacturing Services LLC		079415560	MANUFACTURE(63552-003) , ANALYSIS(63552-003) , PACK(63552-003)

Revised: 2/2019

Document Id: b4945293-ebd8-4d8d-8954-881a1bbb1876

53409-9

Set id: 93bd6842-1400-4713-9277-4951f7ed6b18

Version: 2

Effective Time: 20190219

 

Patheon Manufacturing Services LLC