Darzalex IV

NDC 57894-505 · Janssen Biotech, Inc.

Generic nameDaratumumab

Dosage formINJECTION, SOLUTION, CONCENTRATE

RouteINTRAVENOUS

Active ingredient(s)DARATUMUMAB

Strength100 mg/5mL

Pharmacologic classAntibodies, Monoclonal [CS], CD38-directed Antibody Interactions [MoA], CD38-directed Cytolytic Antibody [EPC]

Marketing categoryBLA

Packages

57894-505-05 — 1 VIAL, SINGLE-DOSE in 1 BOX (57894-505-05) / 5 mL in 1 VIAL, SINGLE-DOSE

57894-505-20 — 1 VIAL, SINGLE-DOSE in 1 BOX (57894-505-20) / 20 mL in 1 VIAL, SINGLE-DOSE

Billed under HCPCS

J9145 — Injection, daratumumab, 10 mg Medicare Part B payment limit (ASP + 6%): $75.23

Related Codes

Same active ingredient

FDA lists these products with the same active ingredient.

57894-502 — Daratumumab, 57894-503 — daratumumab and hyaluronidase-fihj (human recombinant)

From the FDA National Drug Code Directory, retrieved August 24, 2026. Product listings are submitted by labelers; FDA does not verify them.

Read from: FDA National Drug Code Directory, product.txt and package.txt (accessdata.fda.gov/cder/ndctext.zip) — Snapshot retrieved 2026-08-24, loaded 2026-08-24; CMS Medicare Part B Drug Average Sales Price (ASP) Pricing Files (cms.gov/medicare/payment/part-b-drugs/asp-pricing-files) -- the NDC-HCPCS crosswalk and Part B payment limit files — 2026 Q4 (October 2026 release). All data sources · How to read the labels

Current data releases:ICD-10-CM FY2027 · ICD-10-PCS FY2027 · HCPCS October 2026 · MS-DRG v44 · Medicare Code Editor v44.0 · NCCI PTP Q4 2026 · MUE Q4 2026 · NCD code lists 2026-01 · LCD export September 28, 2026 · All releases and sources