What is NDC 57894-160?

57894-160 is the product NDC for Infliximab, Infliximab 100 mg/10mL injection, powder, lyophilized, for solution, listed with the FDA by Janssen Biotech, Inc.. It has 1 package NDC, 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 Infliximab?

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

Infliximab NDC 57894-160 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)57894-160Labeler and product segments. Claims need a package NDC.

Product NDC at billing width57894-0160Add 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
57894-160-01	5789401600157894016001	1 VIAL, SINGLE-USE in 1 BOX (57894-160-01) / 10 mL in 1 VIAL, SINGLE-USEMarketed from Oct 5, 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): Infliximab
Generic name (nonproprietary): infliximab
Active ingredients: Infliximab — 100 mg/10mL
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intravenous
Labeler: Janssen Biotech, Inc.NDC labeler code 57894
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 103772
Marketing start: Oct 5, 2021
Listing expires: Dec 31, 2027
Other FDA classes: Tumor Necrosis Factor Receptor Blocking Activity (Mechanism)
Identifiers: Product ID 57894-160_3bfeaa57-8d95-4bc9-8bb5-274271688470SPL ID 3bfeaa57-8d95-4bc9-8bb5-274271688470SPL set ID b05c174f-832c-4321-b34f-2c4ad3742269RxCUI 310994UNII B72HH48FLU
Pharmacologic class: Tumor Necrosis Factor Blocker

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

J1745 — Injection, infliximab, excludes biosimilar, 10 mg

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

Infliximab biosimilars have their own HCPCS codes.

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

N457894016001 followed by a unit qualifier and the quantity

Package 57894-0160-01. 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 Feb 11, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Infliximab is a tumor necrosis factor (TNF) blocker indicated for: Crohn's Disease : reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. ( 1.1 ) reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing disease. ( 1.1 ) Pediatric Crohn's Disease : reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active disease who have had an inadequate response to conventional thera…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 57894-160

What is NDC 57894-160?: 57894-160 is the product NDC for Infliximab, Infliximab 100 mg/10mL injection, powder, lyophilized, for solution, 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?: Infliximab.
What is the active ingredient?: Infliximab.
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 Infliximab?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Yes: J1745, Injection, infliximab, excludes biosimilar, 10 mg. See Billing references above.

Other NDCs under BLA 103772

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

FDA NDC Directory listings under BLA 103772
Product	Strength	Form · route	Labeler	Product NDC
Remicadeinfliximab	Infliximab 100 mg/10mL	Injection, Powder, Lyophilized, For solutionIntravenous	Janssen Biotech, Inc.	57894-030