TIROFIBAN HYDROCHLORIDE - tirofiban hydrochloride injection 
Amdipharm Limited

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TIROFIBAN HYDROCHLORIDE INJECTION

PRINCIPAL DISPLAY PANEL - Shipping Label

48 UNLABELED 50mL VIALS

MFG DATE: MMM-YYYY

LOT: ??????


PATHEON PRODUCT CODE: 011287


MANUFACTURED FOR:

AMDIPHARM LIMITED


MANUFACTURED BY:

PATHEON MANUFACTURING SERVICES LLC

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: 529268


tirofiban

TIROFIBAN HYDROCHLORIDE 
tirofiban hydrochloride injection
Product Information
Product TypeBULK INGREDIENTItem Code (Source)NDC:82169-025
Route of AdministrationNOT APPLICABLE
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TIROFIBAN HYDROCHLORIDE (UNII: 6H925F8O5J) (TIROFIBAN - UNII:GGX234SI5H) TIROFIBAN HYDROCHLORIDE0.25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82169-025-5048 in 1 CASE01/01/2022
150 mL in 1 VIAL, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
EXPORT ONLY01/01/2022
Labeler - Amdipharm Limited (985749279)

Revised: 3/2022
Document Id: 70e5318a-487c-444f-ba0d-f15b0b5d7b8f
Set id: 5cd35e38-b820-4309-ab72-b2111c769b4c
Version: 2
Effective Time: 20220328
 
Amdipharm Limited