Simponi (golimumab) NDC 57894-071

NDC codes

FDA NDC Directory

Product NDC (as listed)57894-071Labeler and product segments. Claims need a package NDC.

Product NDC at billing width57894-0071Add 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
57894-071-01	57894007101	1 SYRINGE, GLASS in 1 CARTON (57894-071-01) / 1 mL in 1 SYRINGE, GLASSMarketed from May 15, 2013
57894-071-02	57894007102	1 SYRINGE in 1 CARTON (57894-071-02) / 1 mL in 1 SYRINGEMarketed from May 15, 2013
57894-071-89	57894007189	1 SYRINGE in 1 CARTON (57894-071-89) / 1 mL in 1 SYRINGEMarketed from May 15, 2013 · Sample package
57894-071-90	57894007190	1 SYRINGE, GLASS in 1 CARTON (57894-071-90) / 1 mL in 1 SYRINGE, GLASSMarketed from May 15, 2013 · Sample package

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): Simponi
Generic name (nonproprietary): golimumab
Active ingredients: Golimumab — 100 mg/mL
Dosage form: Injection, Solution
Route: Subcutaneous
Labeler: Janssen Biotech, Inc.
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 125289
Marketing start: May 15, 2013
Listing expires: Dec 31, 2027
Other FDA classes: Tumor Necrosis Factor Receptor Blocking Activity (Mechanism)
Identifiers: Product ID 57894-071_7c8722a0-d4ef-43a8-aa00-219ea4cbfcdeSPL ID 7c8722a0-d4ef-43a8-aa00-219ea4cbfcde
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 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

N457894007101 followed by a unit qualifier and the quantity

Package 57894-0071-01. 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

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

Other NDCs under BLA 125289

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

FDA NDC Directory listings under BLA 125289
Product	Strength	Form · route	Labeler	Product NDC
Simponigolimumab	Golimumab 50 mg/.5mL	Injection, SolutionSubcutaneous	Janssen Biotech, Inc.	57894-070