Prescription drug · BLA
Simponi (Golimumab) NDC 57894-070
Golimumab 50 mg/.5mL · Injection, Solution · Subcutaneous · Janssen Biotech, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57894-070-01 | 5789400700157894007001 | 1 SYRINGE, GLASS in 1 CARTON (57894-070-01) / .5 mL in 1 SYRINGE, GLASSMarketed from Apr 25, 2009 | |
| 57894-070-02 | 5789400700257894007002 | 1 SYRINGE in 1 CARTON (57894-070-02) / .5 mL in 1 SYRINGEMarketed from Apr 25, 2009 | |
| 57894-070-89 | 5789400708957894007089 | 1 SYRINGE in 1 CARTON (57894-070-89) / .5 mL in 1 SYRINGEMarketed from Apr 25, 2009 · Sample package | |
| 57894-070-90 | 5789400709057894007090 | 1 SYRINGE, GLASS in 1 CARTON (57894-070-90) / .5 mL in 1 SYRINGE, GLASSMarketed from Apr 25, 2009 · 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 — 50 mg/.5mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Janssen Biotech, Inc.NDC labeler code 57894
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125289
- Marketing start
- Listing expires
- Other FDA classes
- Tumor Necrosis Factor Receptor Blocking Activity (Mechanism)
- Identifiers
- Product ID 57894-070_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.
- NDC on a medical claim
N457894007001followed by a unit qualifier and the quantityPackage 57894-0070-01. 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.
About NDC 57894-070
- What is NDC 57894-070?
- 57894-070 is the product NDC for Simponi (golimumab), Golimumab 50 mg/.5mL injection, solution, listed with the FDA by Janssen Biotech, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Simponi (Golimumab).
- What is the active ingredient?
- Golimumab.
- 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 Simponi?
- 1 other product NDC are listed under this name. See all Simponi NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Simponi products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Simponigolimumab | Golimumab 100 mg/mL | Injection, SolutionSubcutaneous | Janssen Biotech, Inc. | 57894-071 | 57894-0071-0157894-0071-0257894-0071-89+1 more |
Other NDCs under BLA 125289
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Simponigolimumab | Golimumab 100 mg/mL | Injection, SolutionSubcutaneous | Janssen Biotech, Inc. | 57894-071 |