NDC Code(s) : 57894-502-05, 57894-502-20, 57894-505-05, 57894-505-20
Packager : Janssen Biotech, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DARZALEXDaratumumab 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(UNII: 4Z63YK6E0E)
(DARATUMUMAB - UNII:4Z63YK6E0E) 		DARATUMUMAB100 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ACETIC ACID(UNII: Q40Q9N063P)
SODIUM ACETATE(UNII: 4550K0SC9B)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
MANNITOL(UNII: 3OWL53L36A)
POLYSORBATE 20(UNII: 7T1F30V5YH)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:57894-502-051 in 1 CARTON 16/11/2015
15 mL in 1 VIAL Type 0: Not a Combination Product
2NDC:57894-502-201 in 1 CARTON 16/11/2015
220 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761036 11/16/2015
Darzalex IVDaratumumab INJECTION, SOLUTION, CONCENTRATE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57894-505
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DARATUMUMAB(UNII: 4Z63YK6E0E)
(DARATUMUMAB - UNII:4Z63YK6E0E) 		DARATUMUMAB100 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
HISTIDINE(UNII: 4QD397987E)
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATE(UNII: X573657P6P)
METHIONINE(UNII: AE28F7PNPL)
POLYSORBATE 20(UNII: 7T1F30V5YH)
SORBITOL(UNII: 506T60A25R)
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color yellow (colorless to yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:57894-505-051 in 1 BOX 15/10/2021
15 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
2NDC:57894-505-201 in 1 BOX 15/10/2021
220 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761036 10/15/2021

LABELER - Janssen Biotech, Inc.(099091753)

Establishment
Name Address ID/FEI Business Operations
Janssen Biotech, Inc. 038978363 analysis(57894-502, 57894-505)

Establishment
Name Address ID/FEI Business Operations
AndersonBrecon, Inc. 053217022 pack(57894-502)

Establishment
Name Address ID/FEI Business Operations
FUJIFILM Diosynth Biotechnologies Denmark ApS 307258082 api manufacture(57894-505)

Establishment
Name Address ID/FEI Business Operations
Vetter Pharma Fertigung GmbH & Co. KG 312670654 manufacture(57894-502), analysis(57894-502)

Establishment
Name Address ID/FEI Business Operations
Vetter Pharma Fertigung GmbH & Co. KG 316126754 analysis(57894-502)

Establishment
Name Address ID/FEI Business Operations
Vetter Pharma Fertigung GmbH & Co. KG 341629292 analysis(57894-502)

Establishment
Name Address ID/FEI Business Operations
Vetter Pharma Fertigung GmbH & Co. KG 344217323 analysis(57894-502)

Establishment
Name Address ID/FEI Business Operations
Janssen Biologics B.V. 409612918 analysis(57894-502, 57894-505)

Establishment
Name Address ID/FEI Business Operations
Cilag AG 483237103 manufacture(57894-502, 57894-505), pack(57894-502, 57894-505), label(57894-502, 57894-505), analysis(57894-502, 57894-505)

Establishment
Name Address ID/FEI Business Operations
Samsung Biologics Co, LTD 557810567 api manufacture(57894-502), analysis(57894-502)

Establishment
Name Address ID/FEI Business Operations
Baxter Pharmaceutical Solutions, LLC 604719430 manufacture(57894-502), label(57894-502), pack(57894-502)

Establishment
Name Address ID/FEI Business Operations
Biogen, MA Inc. 841087823 api manufacture(57894-502)

Establishment
Name Address ID/FEI Business Operations
PPD Development Ireland Ltd. 985036175 analysis(57894-502)

Establishment
Name Address ID/FEI Business Operations
Janssen Sciences Ireland Unlimited Company 986030167 analysis(57894-502, 57894-505)

PRINCIPAL DISPLAY PANEL

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

darzalex 20mg 5ml

PRINCIPAL DISPLAY PANEL

NDC 57894-505-05

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

For Intravenous Infusion Only
Dilute Before Use
Rx only
One 5 mL Vial
Single-dose vial.
Discard unused portion.

janssen

darzalex-20ml 5mg