TIROFIBAN HYDROCHLORIDE INJECTION

PRINCIPAL DISPLAY PANEL - Shipping Label

48 UNLABELED 50mL VIALS

MFG DATE: MMM-YYYY
LOT: ??????

PATHEON PRODUCT CODE: 011289

MANUFACTURED FOR:
CORREVIO LLC
1350 EDGEMONT AVENUE
CHESTER, PA 19013

MANUFACTURE BY:
PATHEON MANUFACTURING SERVICES LLC
FORMERLY DSM PHARMACEUTICALS, INC
GREENVILLE, NC 27834 USA

FOR EXPORT ONLY

TIROFIBAN HYDROCHLORIDE INJECTION
250 MCG PER mL

STORE AT 25°C (77°F) WITH EXCURSIONS PERMITTED BETWEEN 15°C - 30°C (59°F - 86°F).
(SEE USP CONTROLLED ROOM TEMPERATURE). DO NOT FREEZE.
PROTECT FROM LIGHT DURING STORAGE.
NOT FOR RETAIL SALE. FOR REPACKING ONLY.
Rx ONLY

LABEL: 510119

TIROFIBAN HYDROCHLORIDE
tirofiban hydrochloride injection

Product Information
Product Type	BULK INGREDIENT	Item Code (Source)	NDC:69787-025
Route of Administration	NOT APPLICABLE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Tirofiban Hydrochloride (UNII: 6H925F8O5J) (Tirofiban - UNII:GGX234SI5H)	Tirofiban Hydrochloride	0.25 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Anhydrous Citric Acid (UNII: XF417D3PSL)	0.16 mg in 1 mL
Trisodium Citrate Dihydrate (UNII: B22547B95K)	2.7 mg in 1 mL
Sodium Chloride (UNII: 451W47IQ8X)	8 mg in 1 mL
Water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69787-025-50	48 in 1 CASE	01/01/2008
1		50 mL in 1 VIAL, GLASS

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
EXPORT ONLY		01/01/2008

Labeler - Correvio LLC (965057370)

Name	Address	ID/FEI	Business Operations
Establishment
Patheon Manufacturing Services LLC		079415560	MANUFACTURE(69787-025) , ANALYSIS(69787-025) , PACK(69787-025)

Name	Address	ID/FEI	Business Operations
Establishment
Orion Corporation		539763727	PACK(69787-025)

Revised: 1/2018

Document Id: 7da653c7-b8a2-4449-a821-666d34bbd37e

Set id: 0af8aaad-69d4-44ff-bee7-b4d21343e308

Version: 2

Effective Time: 20180116

Correvio LLC