Halaven (Page 7 of 7)

PRINCIPAL DISPLAY PANEL

NDC 62856-389-01
Halaven™
(eribulin mesylate) Injection
1 mg/2 mL
(0.5 mg/mL)For Intravenous Use

PRINCIPAL DISPLAY PANEL
NDC 62856-389-01
Halaven™
(eribulin mesylate) Injection
1 mg/2 mL
(0.5 mg/mL)
For Intravenous Use
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 62856-389-01
Halaven™
(eribulin mesylate) Injection
1 mg/2 mL
(0.5 mg/mL)For Intravenous Use

PRINCIPAL DISPLAY PANEL
NDC 62856-389-01
Halaven™
(eribulin mesylate) Injection
1 mg/2 mL
(0.5 mg/mL)
For Intravenous Use
(click image for full-size original)

HALAVEN eribulin mesylate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62856-389
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ERIBULIN MESYLATE (ERIBULIN) ERIBULIN MESYLATE 0.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
WATER
SODIUM HYDROXIDE
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62856-389-01 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE
1 2 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (62856-389-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA201532 11/15/2010
Labeler — Eisai Inc. (189246791)
Establishment
Name Address ID/FEI Operations
BSP Pharmaceuticals SpA 857007830 analysis (62856-389), manufacture (62856-389)
Establishment
Name Address ID/FEI Operations
Eisai Co., Ltd. 695319983 api manufacture (62856-389)
Establishment
Name Address ID/FEI Operations
Eisai Manufacturing Ltd 219516916 analysis (62856-389), label (62856-389), pack (62856-389)
Establishment
Name Address ID/FEI Operations
NerPharMa S.r.l 338839192 analysis (62856-389), manufacture (62856-389)
Establishment
Name Address ID/FEI Operations
SAFC Inc 605899769 api manufacture (62856-389)

Revised: 09/2022 Eisai Inc.

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