Label: TIROFIBAN HYDROCHLORIDE injection
- NDC Code(s): 82169-025-50
- Packager: Amdipharm Limited
- Category: BULK INGREDIENT
- DEA Schedule: None
- Marketing Status: Export only
Drug Label Information
Updated March 28, 2022
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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
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INGREDIENTS AND APPEARANCE
TIROFIBAN HYDROCHLORIDE
tirofiban hydrochloride injectionProduct Information Product Type BULK INGREDIENT Item Code (Source) NDC:82169-025 Route of Administration NOT APPLICABLE Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TIROFIBAN HYDROCHLORIDE (UNII: 6H925F8O5J) (TIROFIBAN - UNII:GGX234SI5H) TIROFIBAN HYDROCHLORIDE 0.25 mg in 1 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) SODIUM CHLORIDE (UNII: 451W47IQ8X) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82169-025-50 48 in 1 CASE 01/01/2022 1 50 mL in 1 VIAL, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date EXPORT ONLY 01/01/2022 Labeler - Amdipharm Limited (985749279)