TREMFYA

NDC 57894-651 · Janssen Biotech, Inc.

Generic nameguselkumab

Dosage formINJECTION

RouteSUBCUTANEOUS

Active ingredient(s)GUSELKUMAB

Strength200 mg/2mL

Pharmacologic classInterleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]

Marketing categoryBLA

Packages

57894-651-02 — 1 SYRINGE in 1 CARTON (57894-651-02) / 2 mL in 1 SYRINGE (57894-651-01)

57894-651-04 — 2 CARTON in 1 CARTON (57894-651-04) / 1 SYRINGE in 1 CARTON (57894-651-02) / 2 mL in 1 SYRINGE (57894-651-01)

57894-651-22 — 1 SYRINGE in 1 CARTON (57894-651-22) / 2 mL in 1 SYRINGE (57894-651-11)

57894-651-92 — 1 SYRINGE in 1 CARTON (57894-651-92) / 2 mL in 1 SYRINGE (57894-651-99)

Billed under HCPCS

J1628 — Injection, guselkumab, 1 mg Medicare Part B payment limit (ASP + 6%): $67.00

Related Codes

Same active ingredient

FDA lists these products with the same active ingredient.

57894-640 — Guselkumab, 57894-650 — Guselkumab

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