Label: HALAVEN- eribulin mesylate injection
- NDC Code(s): 43624-002-01
- Packager: BSP Pharmaceuticals SpA
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated November 22, 2023
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- Halaven®
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PRINCIPAL DISPLAY PANEL - SHIPPER LABEL
Eisai Manufacturing Limited
Allegato DQA-035/XXXX
New Chemical Entity Demand Chain Unit European Knowledge Centre
Mosquito Way-Hatfield, Herts, AL 109SN
United Kingdom
HALAVEN®
(eribulin mesylate) Injection, for intravenous use- 0.5mg/ml, 2 ml
Store at 15° - 25°C (59° - 77°F). DO NOT FREEZEQTY: 00XXX EXP: MM-YYYY LOT: F1XXYZZZ
(22) 900XXX MMYYYY F1XXYZZZ 7NDC 43624-002-01
(0X) 50X XXXXX 00X X X0 XXX
Manufactured by : BSP Pharmaceuticals SpA-Latina Scalo, Italy.
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INGREDIENTS AND APPEARANCE
HALAVEN
eribulin mesylate injectionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43624-002 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ERIBULIN MESYLATE (UNII: AV9U0660CW) (ERIBULIN - UNII:LR24G6354G) ERIBULIN MESYLATE 0.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) Product Characteristics Color white (clear, colorless, sterile solution for intravenous administration) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43624-002-01 100 in 1 BOX, UNIT-DOSE 04/21/2017 1 3 mL in 1 TRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA201532 04/21/2017 Labeler - BSP Pharmaceuticals SpA (857007830) Registrant - BSP Pharmaceuticals SpA (857007830) Establishment Name Address ID/FEI Business Operations BSP Pharmaceuticals SpA 857007830 manufacture(43624-002)