Label: SUGAMMADEX injection
- NDC Code(s): 63552-003-01
- Packager: Patheon Manufacturing Services LLC
- Category: BULK INGREDIENT
- DEA Schedule: None
- Marketing Status: Export only
Drug Label Information
Updated September 12, 2022
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PRINCIPAL DISPLAY PANEL - Shipping Label
LOT NUMBER: ??????
MFG. DATE: DD/MMM/YYYYMERCK PRODUCT CODE: 2015541
QU: 192 UNLABELED VIALSSUGAMMADEX 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, USAFOR:
MERCK SHARP & DOHME LLC:
A SUBSIDIARY OF MERCK & CO., INC.,
RAHWAY, NJ 07065 USAMADE IN U.S.A.
LABEL NO: 529884
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INGREDIENTS AND APPEARANCE
SUGAMMADEX
sugammadex injectionProduct 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 - UNII:361LPM2T56) 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)