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Daratumumab and Hyaluronidase-fihj Injection

Daratumumab and hyaluronidase-fihj (Darzalex Faspro) is a subcutaneous injection used in adults to treat multiple myeloma, high-risk smoldering multiple myeloma, and newly diagnosed light chain (AL) amyloidosis.

Brand name Darzalex Faspro
Drug classes Cd38-directed Cytolytic Antibody
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 6, 2026
Daratumumab and Hyaluronidase-fihj Injection at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Darzalex Faspro pairs daratumumab, an antibody that tags a protein called CD38 on myeloma cells so they are killed directly and by the immune system, with hyaluronidase, an enzyme that loosens tissue so it can go under the skin in minutes. Brand-only since about 2020, it is a mainstay of multiple myeloma combinations and also treats high-risk smoldering myeloma and newly diagnosed AL amyloidosis. Most people tolerate it well after the first dose, noticing tiredness, colds or bowel changes. Watch for allergic-type reactions, most likely with the first injection, and for infections and low blood counts, so report fever or unusual bruising; it can also harm an unborn baby.

Clinical pearls

  • Tell any blood bank or hospital you received it; it disrupts transfusion matching tests for up to 6 months after your last dose.
  • The steroid, acetaminophen and antihistamine given before each dose are there to blunt reactions, so take any after-dose medicines too.
  • Report blurred vision or sudden vision changes promptly, since treatment may be paused for an eye exam.
  • If you could become pregnant, use effective contraception during treatment and for 3 months after the last dose.
How we write & review this content — our editorial policy →
How you get itPrescription only
Comes asInjection
Earliest FDA record2020
Companies listing it with the FDA1
FDA label last updatedSep 3, 2026
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Daratumumab and Hyaluronidase-fihj Injection, written from its FDA label.

What Daratumumab and Hyaluronidase-fihj Injection is used for

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Darzalex Faspro is used in adults for these conditions:

  • Multiple myeloma, newly diagnosed, with other medicines, in patients eligible or ineligible for stem cell transplant
  • Relapsed or refractory multiple myeloma, with other medicines, after prior therapy
  • Multiple myeloma alone, after at least three prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent
  • High-risk smoldering multiple myeloma, alone
  • Newly diagnosed light chain (AL) amyloidosis, with bortezomib, cyclophosphamide and dexamethasone

It is not recommended for AL amyloidosis with NYHA Class IIIB or IV cardiac disease or Mayo Stage IIIB outside of controlled clinical trials.

How Daratumumab and Hyaluronidase-fihj Injection works

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Daratumumab is an antibody that binds to CD38, a protein found on myeloma and amyloidosis plasma cells. This can cause cell death directly and help the immune system attack these cells.

Hyaluronidase temporarily breaks down a substance under the skin so the medicine can be absorbed. Its effect wears off within 24 to 48 hours.

Daratumumab and Hyaluronidase-fihj Injection dosage

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Darzalex Faspro is injected under the skin of the abdomen by a healthcare professional over about 3 to 5 minutes.

  • Doses usually start weekly, then space out to every 2 or 3 weeks, then every 4 weeks.
  • The schedule depends on your condition and the other medicines used.
  • You get pre-medications 1 to 3 hours before each dose.
  • Missed doses should be given as soon as possible, with the schedule adjusted.

Dosing details from the FDA-approved label

From the Daratumumab and Hyaluronidase-fihj Injection prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Multiple myeloma: monotherapy, or in combination with lenalidomide and dexamethasone, pomalidomide and dexamethasone, or carfilzomib and dexamethasone (4-week cycle)
    • 1,800 mg/30,000 units (1,800 mg daratumumab and 30,000 units hyaluronidase) administered subcutaneously over approximately 3 to 5 minutes
    • Weeks 1 to 8: weekly (total of 8 doses)
    • Weeks 9 to 24: every two weeks (total of 8 doses)
    • Week 25 onwards until disease progression: every four weeks
  • Multiple myeloma: in combination with bortezomib, melphalan and prednisone (6-week cycle)
    • 1,800 mg/30,000 units subcutaneously over approximately 3 to 5 minutes
    • Weeks 1 to 6: weekly (total of 6 doses)
    • Weeks 7 to 54: every three weeks (total of 16 doses)
    • Week 55 onwards until disease progression: every four weeks
  • Multiple myeloma: in combination with bortezomib, thalidomide and dexamethasone (4-week cycle)
    • 1,800 mg/30,000 units subcutaneously over approximately 3 to 5 minutes
    • Induction: Weeks 1 to 8 weekly (total of 8 doses)
    • Weeks 9 to 16 every two weeks (total of 4 doses)
    • Stop for high dose chemotherapy and ASCT. Consolidation: Weeks 1 to 8 every two weeks (total of 4 doses) upon re-initiation of treatment following ASCT
  • Multiple myeloma: in combination with bortezomib, lenalidomide and dexamethasone (4-week cycle), patients eligible for ASCT
    • 1,800 mg/30,000 units subcutaneously over approximately 3 to 5 minutes
    • Induction: Weeks 1 to 8 weekly (total of 8 doses)
    • Weeks 9 to 16 every two weeks (total of 4 doses)
    • Stop for high dose chemotherapy and ASCT. Consolidation: Weeks 1 to 8 every two weeks (total of 4 doses) upon re-initiation of treatment following ASCT
  • Multiple myeloma: in combination with bortezomib, lenalidomide and dexamethasone (3-week cycle), patients ineligible for ASCT
    • 1,800 mg/30,000 units subcutaneously over approximately 3 to 5 minutes
    • Weeks 1 to 6: weekly (total of 6 doses)
    • Weeks 7 to 24: every three weeks (total of 6 doses)
    • Week 25 onwards until disease progression: every four weeks
  • Multiple myeloma: in combination with bortezomib and dexamethasone (3-week cycle)
    • 1,800 mg/30,000 units subcutaneously over approximately 3 to 5 minutes
    • Weeks 1 to 9: weekly (total of 9 doses)
    • Weeks 10 to 24: every three weeks (total of 5 doses)
    • Week 25 onwards until disease progression: every four weeks
  • High-risk smoldering multiple myeloma: monotherapy (4-week cycle)
    • 1,800 mg/30,000 units subcutaneously over approximately 3 to 5 minutes
    • Weeks 1 to 8: weekly (total of 8 doses)
    • Weeks 9 to 24: every two weeks (total of 8 doses)
    • Week 25 onwards until diagnosis of multiple myeloma or a maximum of 3 years: every four weeks
  • Light chain amyloidosis: in combination with bortezomib, cyclophosphamide and dexamethasone (4-week cycle)
    • 1,800 mg/30,000 units subcutaneously over approximately 3 to 5 minutes
    • Weeks 1 to 8: weekly (total of 8 doses)
    • Weeks 9 to 24: every two weeks (total of 8 doses)
    • Week 25 onwards until disease progression or a maximum of 2 years: every four weeks
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. ( 2.6 ) The recommended dosage of DARZALEX FASPRO is (1,800 mg daratumumab and 30,000 units hyaluronidase) administered subcutaneously into the abdomen over approximately 3 to 5 minutes according to recommended schedule. ( 2.2 , 2.3 , 2.4 ) Administer post-medications as recommended. ( 2.6 ) 2.1 Important Dosing Information DARZALEX FASPRO is for subcutaneous use only. Administer medications before and after administration of DARZALEX FASPRO to minimize administration-related reactions [see Dosage and Administration (2.6) ] . Type and screen patients prior to starting DARZALEX FASPRO. 2.2 Recommended Dosage for Multiple Myeloma The recommended dose of DARZALEX FASPRO is 1,800 mg/30,000 units (1,800 mg daratumumab and 30,000 units hyaluronidase) administered subcutaneously over approximately 3 to 5 minutes. Tables 1, 2, 3, 4, 5, and 6 provide the recommended dosing schedule when DARZALEX FASPRO is administered as monotherapy or as part of a combination therapy. Monotherapy and In Combination with Lenalidomide and Dexamethasone (DARZALEX FASPRO-Rd), Pomalidomide and Dexamethasone (DARZALEX FASPRO-Pd) or Carfilzomib and Dexamethasone (DARZALEX FASPRO-Kd) Use the dosing schedule provided in Table 1 when DARZALEX FASPRO is administered: in combination with lenalidomide and dexamethasone (4-week cycle) OR in combination with pomalidomide and dexamethasone (4-week cycle) OR in combination with carfilzomib and dexamethasone (4-week cycle) OR as monotherapy. Table 1: DARZALEX FASPRO dosing schedule in combination with lenalidomide, pomalidomide or carfilzomib and dexamethasone (4-week cycle) and for monotherapy Weeks Schedule Weeks 1 to 8 weekly (total of 8 doses) Weeks 9 to 24 First dose of the every-2-week dosing schedule is given at Week 9 every two weeks (total of 8 doses) Week 25 onwards until disease progression First dose of the every-4-week dosing schedule is given at Week 25 every four weeks When DARZALEX FASPRO is administered as part of a combination therapy, see Clinical Studies (14.2) and the prescribing information for dosage recommendations for the other drugs.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Daratumumab and Hyaluronidase-fihj Injection side effects

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Common side effects include:

Common side effects

  • Upper respiratory tract infection
  • Fatigue
  • Diarrhea
  • Constipation
  • Nausea
  • Fever
  • Peripheral neuropathy (nerve numbness or tingling)
  • Low blood counts on lab tests
  • Low white cells, platelets, and hemoglobin on lab tests

When to get medical help

  • Get help right away for allergic or infusion-type reactions such as trouble breathing, wheezing, chest pain, swelling, severe itching, or a fast heartbeat.
  • Tell your care team promptly about eye symptoms such as blurred vision or sudden vision changes. Treatment may need to be paused for an eye exam.
  • Call your doctor for signs of infection such as fever, chills, or cough. Serious and fatal infections can occur.
  • If you have AL amyloidosis with heart involvement, report new heart symptoms. Serious and fatal heart problems occurred in this group.
  • Report unusual bruising or bleeding, or signs of low blood counts.
  • Report injection-site redness, rash, or other reactions.

Daratumumab and Hyaluronidase-fihj Injection warnings and precautions

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  • Administration reactions: can be severe or fatal, most often with the first injection. Treatment is permanently stopped for life-threatening reactions.
  • Heart problems in AL amyloidosis: serious and fatal cardiac events occurred.
  • Infections: can be serious or fatal, including pneumonia.
  • Low neutrophils and platelets: blood counts are checked regularly.
  • Pregnancy: can cause fetal harm.
  • Lab test interference: affects blood bank and myeloma monitoring tests.

Daratumumab and Hyaluronidase-fihj Injection interactions

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The label mainly describes interference with lab tests and combination cautions.

  • Blood bank cross-matching and antibody screening can be affected, so tell blood banks about your treatment.
  • Myeloma monitoring tests can show false positives, affecting how response is judged.
  • Combining it with lenalidomide, thalidomide or pomalidomide is contraindicated in pregnancy.

Interactions listed in the FDA-approved label

From the Daratumumab and Hyaluronidase-fihj Injection prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Indirect antiglobulin tests (indirect Coombs test): Daratumumab binds to CD38 on RBCs and interferes with compatibility testing, including antibody screening and cross matching. Mitigation methods include treating reagent RBCs with dithiothreitol (DTT) or genotyping. Since the Kell blood group system is also sensitive to DTT treatment, supply K-negative units after ruling out or identifying alloantibodies using DTT-treated RBCs. If an emergency transfusion is required, administer non-cross-matched ABO/RhD-compatible RBCs per local b
  • Serum protein electrophoresis (SPE) and immunofixation (IFE) tests: Daratumumab may be detected on SPE and IFE assays used to monitor monoclonal immunoglobulins (M protein); false positive results may occur for patients with IgG kappa myeloma protein, impacting initial assessment of complete responses by IMWG criteria. In patients with persistent very good partial response where daratumumab interference is suspected, consider using an FDA-approved daratumumab-specific IFE assay to distinguish daratumumab from any remaining endogenous M protein, to facilitate determination of a complete response.
Read the label’s full interactions text

7 DRUG INTERACTIONS 7.1 Effects of Daratumumab on Laboratory Tests Interference with Indirect Antiglobulin Tests (Indirect Coombs Test) Daratumumab binds to CD38 on RBCs and interferes with compatibility testing, including antibody screening and cross matching. Daratumumab interference mitigation methods include treating reagent RBCs with dithiothreitol (DTT) to disrupt daratumumab binding [see References (15) ] or genotyping. Since the Kell blood group system is also sensitive to DTT treatment, supply K-negative units after ruling out or identifying alloantibodies using DTT-treated RBCs. If an emergency transfusion is required, administer non-cross-matched ABO/RhD-compatible RBCs per local blood bank practices. Interference with Serum Protein Electrophoresis and Immunofixation Tests Daratumumab may be detected on serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for monitoring disease monoclonal immunoglobulins (M protein). False positive SPE and IFE assay results may occur for patients with IgG kappa myeloma protein impacting initial assessment of complete responses by International Myeloma Working Group (IMWG) criteria. In DARZALEX FASPRO-treated patients with persistent very good partial response, where daratumumab interference is suspected, consider using a FDA-approved daratumumab-specific IFE assay to distinguish daratumumab from any remaining endogenous M protein in the patient's serum, to facilitate determination of a complete response.

Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Check Daratumumab and Hyaluronidase-fihj Injection against a supplement or herb →

Before taking Daratumumab and Hyaluronidase-fihj Injection

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  • Do not use it with a history of severe allergy to daratumumab, hyaluronidase, or any ingredient.
  • Tell your doctor if you are pregnant or planning pregnancy.
  • Use effective contraception during treatment and for 3 months after the last dose.
  • Avoid breastfeeding during treatment.
  • Safety in children is not established.
  • Tell your doctor about heart involvement from AL amyloidosis or any infection.

What Daratumumab and Hyaluronidase-fihj Injection does in the body

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Natural killer (NK) immune cells also carry CD38, so daratumumab lowers their numbers in blood and bone marrow. It is a large protein and is not expected to affect heart rhythm. The relationship between drug levels and its effects has not been fully worked out.

How your body processes Daratumumab and Hyaluronidase-fihj Injection

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About 69% of the injected dose is absorbed, with peak levels in around 3 days in multiple myeloma and 4 days in AL amyloidosis. Levels build up with repeated weekly dosing. Half-life is about 20 days in multiple myeloma and 28 days in AL amyloidosis. Sex, age, kidney impairment, and mild liver impairment had no meaningful effect on levels.

How to store Daratumumab and Hyaluronidase-fihj Injection

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Store DARZALEX FASPRO vials in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze or shake.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

Daratumumab and Hyaluronidase-fihj Injection: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Daratumumab and Hyaluronidase-fihj Injection — the kind of thing our pharmacy team would talk through with you at the counter.

What is this medicine for?

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Darzalex Faspro treats multiple myeloma, high-risk smoldering multiple myeloma, and newly diagnosed AL amyloidosis in adults. Which one applies, and what it is combined with, depends on your situation.

How is it given?

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It is a shot under the skin of your abdomen, given by a healthcare professional over about 3 to 5 minutes. Doses start weekly and space out over time. If one is missed, we give it as soon as possible and adjust the schedule.

Why do I get other medicines first?

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You get a steroid, acetaminophen, and an antihistamine before each dose to lower the chance of reactions. You may get medicines afterward too. Reactions are most likely with the first injection.

What side effects should I expect?

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Common ones include colds or upper respiratory infections, tiredness, diarrhea, constipation, nausea, fever, and nerve tingling. Call right away for breathing trouble, chest pain, vision changes, fever or other signs of infection.

Does it affect blood tests?

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Yes. It can interfere with blood bank cross-matching for up to 6 months after the last dose, so tell any hospital or blood bank you have had it. It can also affect myeloma monitoring tests.

Is it safe in pregnancy?

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It can harm an unborn baby. If you can become pregnant, use effective contraception during treatment and for 3 months after the last dose. Breastfeeding is not advised during treatment.

Is Daratumumab and Hyaluronidase-fihj Injection available over the counter?

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No. Daratumumab and Hyaluronidase-fihj Injection is a prescription medicine: every Daratumumab and Hyaluronidase-fihj Injection product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Daratumumab and Hyaluronidase-fihj Injection first available?

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The earliest FDA record we hold for Daratumumab and Hyaluronidase-fihj Injection is from 2020: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Daratumumab and Hyaluronidase-fihj Injection was first used.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Daratumumab and Hyaluronidase-fihj Injection on HelloPharmacist

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Detailed data & references for Daratumumab and Hyaluronidase-fihj Injection Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Daratumumab and Hyaluronidase-fihj Injection forms and strengths (how it comes)

Daratumumab and Hyaluronidase-fihj Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Daratumumab and Hyaluronidase-fihj Injection inactive ingredients by manufacturer.

Injection

Under the skin
Brands Darzalex Faspro
How this form is used
What it may be used for
  • Darzalex Faspro is used for multiple myeloma, alone or with other medicines depending on prior treatment.
  • Darzalex Faspro alone is used for high-risk smoldering multiple myeloma.
  • Darzalex Faspro is used with bortezomib, cyclophosphamide and dexamethasone for newly diagnosed AL amyloidosis.
Important instructions
  • Darzalex Faspro is for subcutaneous use only, injected into the abdomen over about 3 to 5 minutes.
  • Darzalex Faspro is given after pre-medication with a corticosteroid, acetaminophen and an antihistamine.
  • Darzalex Faspro patients need a blood type and screen before starting.
  • Darzalex Faspro missed doses should be given as soon as possible, with the schedule adjusted.
Available strengths 2 strengths
DARATUMUMAB 1800 mg/15 mL; HYALURONIDASE (HUMAN RECOMBINANT) 30000 U/15 mL 1800; 30000 mg/15 mL; U/15 mL
4 FDA-listed product records ⓘ

Daratumumab and Hyaluronidase-fihj Injection on the U.S. market: products, makers and brands

How Daratumumab and Hyaluronidase-fihj Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1 company lists 1 Daratumumab and Hyaluronidase-fihj Injection product record with the FDA, mostly as injection; the earliest marketing or approval year on record is 2020. Brand names on the directory include Darzalex Faspro; the rest are generics.

1
Dose forms ⓘ
1
Labelers (makers, repackagers, distributors)
1
Brand names
1
FDA-listed product records ⓘ
2020
Earliest FDA record ⓘ

How widely Daratumumab and Hyaluronidase-fihj Injection is used (Medicaid data)

A general measure of how commonly Daratumumab and Hyaluronidase-fihj Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Daratumumab and Hyaluronidase-fihj Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

24,846
Medicaid prescriptions filled (Q1–Q4 2025)
$195M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Daratumumab and Hyaluronidase-fihj Injection prescribed? Of the 1,601 medications we measure, Daratumumab and Hyaluronidase-fihj Injection ranks #767 by Medicaid prescriptions — more than 52% of them.

Where Daratumumab and Hyaluronidase-fihj Injection ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #767 of 1,601
#762 Dolutegravir / Rilpivi... 26,206 Rx #763 Succinylcholine 25,454 Rx #764 Irinotecan Injection 25,359 Rx #765 Irinotecan 25,359 Rx #766 Ibandronate 25,078 Rx #767 Daratumumab and Hyalur... 24,846 Rx #768 Fesoterodine 24,735 Rx #769 Netarsudil Ophthalmic 24,727 Rx #770 Dapsone Topical 24,570 Rx #771 Atovaquone 24,509 Rx #772 Spironolactone and Hyd... 24,202 Rx

Utilization by Daratumumab and Hyaluronidase-fihj Injection product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

Other Daratumumab and Hyaluronidase-fihj Injection products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)

24,846 Medicaid prescriptions (Q1–Q4 2025) 100% of Daratumumab and Hyaluronidase-fihj Injection prescriptions shown $195M gross reimbursement (before rebates) ≈ $7,848 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity.

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Daratumumab and Hyaluronidase-fihj Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 1 listed Daratumumab and Hyaluronidase-fihj Injection NDCs with Medicaid activity.

Compare Daratumumab and Hyaluronidase-fihj Injection products

A representative set of FDA-listed product records for Daratumumab and Hyaluronidase-fihj Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Injection
DARATUMUMAB 1800 mg/15 mL; HYALURONIDASE (HUMAN RECOMBINANT) 30000 U/15 mL Subcutaneous Janssen Biotech, Inc. BLA View NDC →

Showing 1 of 1 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1 Daratumumab and Hyaluronidase-fihj Injection NDCs →

Daratumumab and Hyaluronidase-fihj Injection recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Daratumumab and Hyaluronidase-fihj recalls since July 2021.

✅No Daratumumab and Hyaluronidase-fihj recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

Daratumumab and Hyaluronidase-fihj Injection brand names

Daratumumab and Hyaluronidase-fihj Injection is sold under one brand name in the FDA directory — Darzalex Faspro. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Darzalex Faspro

Who makes Daratumumab and Hyaluronidase-fihj Injection: manufacturers and labelers

One company lists Daratumumab and Hyaluronidase-fihj Injection products with the FDA. By number of product records, the largest are Janssen Biotech, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Janssen Biotech, Inc. 1

Daratumumab and Hyaluronidase-fihj Injection drug class (RxNorm)

Daratumumab and Hyaluronidase-fihj Injection belongs to the Endoglycosidase class.

Pharmacologic class Endoglycosidase
Drug family (ATC) Enzymes

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Daratumumab and Hyaluronidase-fihj Injection page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Sep 3, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Daratumumab and Hyaluronidase-fihj Injection.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Daratumumab and Hyaluronidase-fihj Injection after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
Finished products in the current FDA directory
1
Companies listing them (makers, repackagers, distributors)
1
FDA labeler codes behind them ⓘ
1
Linked representative label ⓘ
Janssen Biotech, Inc.
Linked label effective
Sep 3, 2026
Composite sections available
22
Linked SPL Set ID
4bb241af-4299-4373-8762-2d6709515db0
Linked SPL Document ID
bf986b71-66e2-4883-9687-f340388abafe
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Janssen Biotech, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →