Parecoxib Sodium: Package Insert and Label Information

PARECOXIB SODIUM- parecoxib sodium injection, powder, for solution
Pharmacia and Upjohn Company

PRINCIPAL DISPLAY PANEL — Shipping Label

264 (5 ML VIALS) 4725-78-901

PARECOXIB SODIUM ( INJECTION) 40 MG

STORE AT 25°C (77°F); EXCURSIONS PERMITTED TO 15-30°C (59-86°F)
PROTECT FROM LIGHT

LOT $$$$$$$$ EXP EM/ECEY

264 (5 ML VIALS)
4725-78-901

PARECOXIB SODIUM ( INJECTION) 40 MG

STORE AT 25°C (77°F); EXCURSIONS PERMITTED TO 15-30°C (59-86°F)
PROTECT FROM LIGHT
FOR MANUFACTURING, PROCESSING, OR REPACKING.
FOR EXPORT ONLY. NOT TO BE SOLD OR OFFERED FOR SALE IN THE USA.
DISTRIBUTED BY: PHARMACIA & UPJOHN COMPANY
KALAMAZOO, MICHIGAN 49001, USA

804 660 002

Shipping Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — Shipping Label — Pallet

4725-78-901

PARECOXIB SODIUM ( INJECTION) 40 MG

STORE AT 25°C (77°F); EXCURSIONS PERMIITTED TO 15-30°C (59-86°F)
PROTECT FROM LIGHT

LOT $$$$$$$$ EXP EM/ECEY

4725-78-901

PARECOXIB SODIUM ( INJECTION) 40 MG

STORE AT 25°C (77°F); EXCURSIONS PERMITTED TO 15-30°C (59-86°F)
PROTECT FROM LIGHT
FOR MANUFACTURING, PROCESSING, OR REPACKING.
FOR EXPORT ONLY. NOT TO BE SOLD OR OFFERED FOR SALE IN THE USA.
DISTRIBUTED BY: PHARMACIA & UPJOHN COMPANY
KALAMAZOO, MICHIGAN 49001, USA

804 661 001

Shipping Label -- Pallet
(click image for full-size original)
PARECOXIB SODIUM
parecoxib sodium injection, powder, for solution
Product Information
Product Type BULK INGREDIENT Item Code (Source) NHRIC:0009-0048
Route of Administration NOT APPLICABLE DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PARECOXIB SODIUM (PARECOXIB) PARECOXIB SODIUM 40 mg
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
PHOSPHORIC ACID
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NHRIC:0009-0048-02 264 VIAL in 1 CONTAINER contains a VIAL (0009-0048-01)
1 NHRIC:0009-0048-01 40 INJECTION, POWDER, FOR SOLUTION in 1 VIAL This package is contained within the CONTAINER (0009-0048-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
EXPORT ONLY 04/01/2013
Labeler — Pharmacia and Upjohn Company (829076566)
Establishment
Name Address ID/FEI Operations
Piramal Healthcare UK Limited 345609965 API MANUFACTURE (0009-0048), PACK (0009-0048)
Establishment
Name Address ID/FEI Operations
Pfizer Pharmaceuticals LLC 829084545 API MANUFACTURE (0009-0048)
Establishment
Name Address ID/FEI Operations
Pharmacia and Upjohn Company 829076566 ANALYSIS (0009-0048), MANUFACTURE (0009-0048), PACK (0009-0048)
Establishment
Name Address ID/FEI Operations
Pfizer Manufacturing Belgium NV 370156507 ANALYSIS (0009-0048), PACK (0009-0048)

Revised: 05/2015 Pharmacia and Upjohn Company

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