Prescription Drug Information: DARZALEX (Page 8 of 8)

PRINCIPAL DISPLAY PANEL — 100 mg/5 mL Vial Carton

NDC 57894-502-05

DARZALEX®
(daratumumab)
Injection
100 mg/5 mL
(20 mg/mL)

For Intravenous Infusion Only
Dilute Before Use
Rx only
Single-dose vial. Discard Unused Portion

janssen

PRINCIPAL DISPLAY PANEL -- 100 mg/5 mL Vial Carton
(click image for full-size original)
DARZALEX daratumumab injection, solution, concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57894-502
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Daratumumab (Daratumumab) Daratumumab 100 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
sodium acetate
sodium chloride
mannitol
polysorbate 20
water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57894-502-05 1 VIAL in 1 CARTON contains a VIAL
1 5 mL in 1 VIAL This package is contained within the CARTON (57894-502-05)
2 NDC:57894-502-20 1 VIAL in 1 CARTON contains a VIAL
2 20 mL in 1 VIAL This package is contained within the CARTON (57894-502-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761036 11/16/2015
Labeler — Janssen Biotech, Inc. (099091753)
Establishment
Name Address ID/FEI Operations
Cilag AG 483237103 MANUFACTURE (57894-502), ANALYSIS (57894-502), PACK (57894-502)
Establishment
Name Address ID/FEI Operations
Vetter Pharma Fertigung GmbH & Co. KG 312670654 MANUFACTURE (57894-502), ANALYSIS (57894-502)
Establishment
Name Address ID/FEI Operations
Janssen Biologics B.V. 409612918 ANALYSIS (57894-502)
Establishment
Name Address ID/FEI Operations
Janssen Biotech, Inc. 038978363 ANALYSIS (57894-502)
Establishment
Name Address ID/FEI Operations
Vetter Pharma Fertigung GmbH & Co. KG 344217323 ANALYSIS (57894-502)
Establishment
Name Address ID/FEI Operations
Vetter Pharma Fertigung GmbH & Co. KG 316126754 ANALYSIS (57894-502)
Establishment
Name Address ID/FEI Operations
Vetter Pharma Fertigung GmbH & Co. KG 341629292 ANALYSIS (57894-502)
Establishment
Name Address ID/FEI Operations
Janssen Sciences Ireland UC 986030167 ANALYSIS (57894-502), API MANUFACTURE (57894-502)
Establishment
Name Address ID/FEI Operations
PPD Development Ireland Ltd. 985036175 ANALYSIS (57894-502)
Establishment
Name Address ID/FEI Operations
AndersonBrecon, Inc. 053217022 PACK (57894-502)
Establishment
Name Address ID/FEI Operations
Biogen, MA Inc. 841087823 API MANUFACTURE (57894-502)
Establishment
Name Address ID/FEI Operations
Samsung Biologics Co, LTD 557810567 API MANUFACTURE (57894-502)
Establishment
Name Address ID/FEI Operations
Baxter Pharmaceutical Solutions, LLC 604719430 MANUFACTURE (57894-502)

Revised: 09/2021 Janssen Biotech, Inc.

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