What is NDC 57894-503?

57894-503 is the product NDC for Darzalex Faspro, Daratumumab 1800 mg/15mL; Hyaluronidase (Human recombinant) 30000 U/15mL injection, listed with the FDA by Janssen Biotech, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Darzalex Faspro (Daratumumab and hyaluronidase-fihj (human recombinant)).

What is the active ingredient?

Daratumumab, Hyaluronidase (Human recombinant).

Janssen Biotech, Inc., NDC labeler code 57894. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Darzalex Faspro?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Darzalex Faspro NDC 57894-503 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)57894-503Labeler and product segments. Claims need a package NDC.

Product NDC at billing width57894-0503Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
57894-503-01	57894050301	1 VIAL, SINGLE-DOSE in 1 BOX (57894-503-01) / 15 mL in 1 VIAL, SINGLE-DOSEMarketed from May 1, 2020

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Darzalex Faspro
Generic name (nonproprietary): daratumumab and hyaluronidase-fihj (human recombinant)
Active ingredients: Daratumumab — 1800 mg/15mLHyaluronidase (Human recombinant) — 30000 U/15mL
Dosage form: Injection
Route: Subcutaneous
Labeler: Janssen Biotech, Inc.NDC labeler code 57894
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 761145
Marketing start: May 1, 2020
Listing expires: Dec 31, 2027
Other FDA classes: Monoclonal (Chemical structure)CD38-directed Antibody Interactions (Mechanism)Glycoside Hydrolases (Chemical structure)
Identifiers: Product ID 57894-503_bf986b71-66e2-4883-9687-f340388abafeSPL ID bf986b71-66e2-4883-9687-f340388abafeSPL set ID 4bb241af-4299-4373-8762-2d6709515db0RxCUI 2375136, 2375141UNII 4Z63YK6E0E, 743QUY4VD8
Pharmacologic class: CD38-directed Cytolytic Antibody; Endoglycosidase

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N457894050301 followed by a unit qualifier and the quantity

Package 57894-0503-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Sep 3, 2026.

Indications (excerpt from the label)

DARZALEX FASPRO is a combination of daratumumab, a CD38-directed cytolytic antibody, and hyaluronidase, an endoglycosidase, indicated for the treatment of adult patients with: multiple myeloma in combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation in newly diagnosed patients who are eligible for autologous stem cell transplant multiple myeloma in combination with bortezomib, lenalidomide, and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant multiple myeloma in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant multiple …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 57894-503

What is NDC 57894-503?: 57894-503 is the product NDC for Darzalex Faspro, Daratumumab 1800 mg/15mL; Hyaluronidase (Human recombinant) 30000 U/15mL injection, listed with the FDA by Janssen Biotech, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Darzalex Faspro (Daratumumab and hyaluronidase-fihj (human recombinant)).
What is the active ingredient?: Daratumumab, Hyaluronidase (Human recombinant).
Who is the labeler?: Janssen Biotech, Inc., NDC labeler code 57894. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Darzalex Faspro?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.