NDC 57894-503

Darzalex Faspro

Daratumumab And Hyaluronidase-fihj (human Recombinant)

Darzalex Faspro is a Subcutaneous Injection in the Human Prescription Drug category. It is labeled and distributed by Janssen Biotech, Inc.. The primary component is Daratumumab; Hyaluronidase (human Recombinant).

Product ID57894-503_31006ad8-638c-11ea-8b95-4d54fc2ca371
NDC57894-503
Product TypeHuman Prescription Drug
Proprietary NameDarzalex Faspro
Generic NameDaratumumab And Hyaluronidase-fihj (human Recombinant)
Dosage FormInjection
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2020-05-01
Marketing CategoryBLA / BLA
Application NumberBLA761145
Labeler NameJanssen Biotech, Inc.
Substance NameDARATUMUMAB; HYALURONIDASE (HUMAN RECOMBINANT)
Active Ingredient Strength1800 mg/15mL; U/15mL
Pharm ClassesCD38-directed Cytolytic Antibody [EPC],CD38-directed Antibody Interactions [MoA],Antibodies, Monoclonal [CS],Endoglycosidase [EPC],Glycoside Hydrolases [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 57894-503-01

1 VIAL, SINGLE-DOSE in 1 BOX (57894-503-01) > 15 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2020-05-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57894-503-01 [57894050301]

Darzalex Faspro INJECTION
Marketing CategoryBLA
Application NumberBLA761145
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-05-01

Drug Details

Active Ingredients

IngredientStrength
DARATUMUMAB1800 mg/15mL

Pharmacological Class

  • CD38-directed Cytolytic Antibody [EPC]
  • CD38-directed Antibody Interactions [MoA]
  • Antibodies
  • Monoclonal [CS]
  • Endoglycosidase [EPC]
  • Glycoside Hydrolases [CS]

Trademark Results [Darzalex Faspro]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DARZALEX FASPRO
DARZALEX FASPRO
88254889 not registered Live/Pending
JOHNSON & JOHNSON
2019-01-09

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