PARECOXIB SODIUM injection, powder, for solution

Parecoxib Sodium by

Drug Labeling and Warnings

Parecoxib Sodium by is a Prescription medication manufactured, distributed, or labeled by Pharmacia and Upjohn Company LLC, Piramal Healthcare UK Limited, Pfizer Pharmaceuticals LLC, Pfizer Manufacturing Belgium NV. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

INGREDIENTS AND APPEARANCE

PARECOXIB SODIUM 
parecoxib sodium injection, powder, for solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0009-0048
Route of Administration	INTRAVENOUS, INTRAMUSCULAR

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PARECOXIB SODIUM (UNII: EB87433V6F) (PARECOXIB - UNII:9TUW81Y3CE)	PARECOXIB SODIUM	40 mg

Inactive Ingredients
Ingredient Name	Strength
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
PHOSPHORIC ACID (UNII: E4GA8884NN)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0009-0048-02	264 in 1 CONTAINER	04/01/2013
1	NDC: 0009-0048-01	40 in 1 VIAL; Type 0: Not a Combination Product

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 LLC (618054084)

Establishment
Name	Address	ID/FEI	Business Operations
Piramal Healthcare UK Limited		345609965	API MANUFACTURE(0009-0048) , PACK(0009-0048)

Establishment
Name	Address	ID/FEI	Business Operations
Pfizer Pharmaceuticals LLC		829084545	API MANUFACTURE(0009-0048)

Establishment
Name	Address	ID/FEI	Business Operations
Pfizer Manufacturing Belgium NV		370156507	ANALYSIS(0009-0048) , PACK(0009-0048)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmacia and Upjohn Company LLC		618054084	ANALYSIS(0009-0048) , MANUFACTURE(0009-0048) , PACK(0009-0048)