What is NDC 57894-505?

57894-505 is the product NDC for Darzalex IV (daratumumab), Daratumumab 100 mg/5mL injection, solution, concentrate, listed with the FDA by Janssen Biotech, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

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 IV?

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

Is there a related HCPCS / J-code?

Yes: J9145, Injection, daratumumab, 10 mg.

Darzalex IV NDC 57894-505 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)57894-505Labeler and product segments. Claims need a package NDC.

Product NDC at billing width57894-0505Add 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
57894-505-05	57894050505	1 VIAL, SINGLE-DOSE in 1 BOX (57894-505-05) / 5 mL in 1 VIAL, SINGLE-DOSEMarketed from Oct 15, 2021
57894-505-20	57894050520	1 VIAL, SINGLE-DOSE in 1 BOX (57894-505-20) / 20 mL in 1 VIAL, SINGLE-DOSEMarketed from Oct 15, 2021

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 IV
Generic name (nonproprietary): daratumumab
Active ingredients: Daratumumab — 100 mg/5mL
Dosage form: Injection, Solution, Concentrate
Route: Intravenous
Labeler: Janssen Biotech, Inc.NDC labeler code 57894
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 761036
Marketing start: Oct 15, 2021
Listing expires: Dec 31, 2027
Other FDA classes: Monoclonal (Chemical structure)CD38-directed Antibody Interactions (Mechanism)
Identifiers: Product ID 57894-505_8a51c997-0984-4b45-ad46-5ee0e29a3deeSPL ID 8a51c997-0984-4b45-ad46-5ee0e29a3dee
Pharmacologic class: CD38-directed Cytolytic Antibody

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 codeMed-Code curated

J9145 — Injection, daratumumab, 10 mg

Billing unit: 10 mg. Units on the claim = dose given ÷ 10 mg.

The subcutaneous daratumumab and hyaluronidase product (Darzalex Faspro) has its own code.

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

N457894050505 followed by a unit qualifier and the quantity

Package 57894-0505-05. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 57894-505

What is NDC 57894-505?: 57894-505 is the product NDC for Darzalex IV (daratumumab), Daratumumab 100 mg/5mL injection, solution, concentrate, listed with the FDA by Janssen Biotech, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Darzalex IV (Daratumumab).
What is the active ingredient?: Daratumumab.
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 IV?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Yes: J9145, Injection, daratumumab, 10 mg. See Billing references above.

Other NDCs under BLA 761036

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under BLA 761036
Product	Strength	Form · route	Labeler	Product NDC
Darzalexdaratumumab	Daratumumab 100 mg/5mL	Injection, Solution, ConcentrateIntravenous	Janssen Biotech, Inc.	57894-502

Darzalex IV (Daratumumab) NDC 57894-505