Darzalex Faspro (Page 8 of 8)

PRINCIPAL DISPLAY PANEL — 15 mL Vial Box

NDC 57894-503-01

DARZALEX Faspro®
(daratumumab and
hyaluronidase-fihj)
Injection

1,800 mg and
30,000 Units/15 mL
(120 mg and 2,000 Units/mL)

For Subcutaneous Use Only

Administer subcutaneous
injection over 3 to 5 minutes.

Rx only

One 15 mL Vial

Single-dose vial.Discard unused portion.

janssen

PRINCIPAL DISPLAY PANEL -- 15 mL Vial Box
(click image for full-size original)
DARZALEX FASPRO daratumumab and hyaluronidase-fihj (human recombinant) injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57894-503
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Daratumumab (Daratumumab) Daratumumab 1800 mg in 15 mL
HYALURONIDASE (HUMAN RECOMBINANT) (HYALURONIDASE (HUMAN RECOMBINANT)) HYALURONIDASE (HUMAN RECOMBINANT) 30000 U in 15 mL
Inactive Ingredients
Ingredient Name Strength
HISTIDINE
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATE
METHIONINE
polysorbate 20
sorbitol
water
Product Characteristics
Color YELLOW (colorless to yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57894-503-01 1 VIAL, SINGLE-DOSE in 1 BOX contains a VIAL, SINGLE-DOSE
1 15 mL in 1 VIAL, SINGLE-DOSE This package is contained within the BOX (57894-503-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761145 05/01/2020
Labeler — Janssen Biotech, Inc. (099091753)
Establishment
Name Address ID/FEI Operations
Biogen (Denmark) Manufacturing ApS 307258082 API MANUFACTURE (57894-503)
Establishment
Name Address ID/FEI Operations
Cilag AG 483237103 MANUFACTURE (57894-503), ANALYSIS (57894-503), PACK (57894-503), LABEL (57894-503)
Establishment
Name Address ID/FEI Operations
Janssen Biotech, Inc. 038978363 API MANUFACTURE (57894-503), ANALYSIS (57894-503)
Establishment
Name Address ID/FEI Operations
Janssen Sciences Ireland UC 986030167 ANALYSIS (57894-503)
Establishment
Name Address ID/FEI Operations
Janssen Biologics B.V. 409612918 ANALYSIS (57894-503)
Establishment
Name Address ID/FEI Operations
Catalent Indiana, LLC 172209277 API MANUFACTURE (57894-503)
Establishment
Name Address ID/FEI Operations
Charles River Laboratories 078495006 ANALYSIS (57894-503)
Establishment
Name Address ID/FEI Operations
Bioreliance Corporation 147227730 ANALYSIS (57894-503)
Establishment
Name Address ID/FEI Operations
Eurofins Lancaster Laboratories, Inc 069777290 ANALYSIS (57894-503)

Revised: 11/2022 Janssen Biotech, Inc.

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