Halaven - DailyMed Details

Halaven

SPL v57

SPL

SPL Set ID 8fc8fe1d-59fe-4e43-a95c-e7aa13422cd6

Route

INTRAVENOUS

Published

Effective Date 2019-12-10

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Eribulin (0.5 mg)

Inactive Ingredients

Alcohol Water

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

NDA Active Since 2017-04-21

Description

(eribulin mesylate) Injection, for intravenous use 1 mg/2 mL (0.5 mg/mL)

Medication Information

Description

(eribulin mesylate) Injection, for intravenous use 1 mg/2 mL (0.5 mg/mL)

Halaven®

(eribulin mesylate) Injection, for intravenous use

1 mg/2 mL (0.5 mg/mL)

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 FREEZE

QTY: 00XXX EXP: MM-YYYY LOT: F1XXYZZZ

(22) 900XXX MMYYYY F1XXYZZZ 7

NDC 43624-002-01

(0X) 50X XXXXX 00X X X0 XXX

Manufactured by : BSP Pharmaceuticals SpA-Latina Scalo, Italy.

Structured Label Content

Halaven®

(eribulin mesylate) Injection, for intravenous use

1 mg/2 mL (0.5 mg/mL)

Principal Display Panel Shipper Label (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 FREEZE

QTY: 00XXX EXP: MM-YYYY LOT: F1XXYZZZ

(22) 900XXX MMYYYY F1XXYZZZ 7

NDC 43624-002-01

(0X) 50X XXXXX 00X X X0 XXX

Manufactured by : BSP Pharmaceuticals SpA-Latina Scalo, Italy.

Advanced Ingredient Data

[{"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ERIBULIN", "unii": "LR24G6354G", "classCode": "ACTIB", "strengthNumerator": "0.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Halaven®": "(eribulin mesylate) Injection, for intravenous use 1 mg/2 mL (0.5 mg/mL)", "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 FREEZE QTY: 00XXX EXP: MM-YYYY LOT: F1XXYZZZ (22) 900XXX MMYYYY F1XXYZZZ 7 NDC 43624-002-01 ( 0X) 50X XXXXX 00X X X0 XXX Manufactured by : BSP Pharmaceuticals SpA-Latina Scalo, Italy. "}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:51:37.181449 · Updated: 2026-03-14T22:41:00.111917