Prescription drug · BLA
Tremfya (Guselkumab) NDC 57894-650
Guselkumab 200 mg/20mL · Injection · Intravenous · Janssen Biotech, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57894-650-02 | 57894065002 | 1 VIAL, SINGLE-DOSE in 1 CARTON (57894-650-02) / 20 mL in 1 VIAL, SINGLE-DOSE (57894-650-01)Marketed from Sep 11, 2024 |
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)
- Tremfya
- Generic name (nonproprietary)
- guselkumab
- Active ingredients
- Guselkumab — 200 mg/20mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Janssen Biotech, Inc.NDC labeler code 57894
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761061
- Marketing start
- Listing expires
- Other FDA classes
- Interleukin-23 Antagonists (Mechanism)
- Identifiers
- Product ID 57894-650_01b4ab20-c027-482f-b358-b9beae545cb3SPL ID 01b4ab20-c027-482f-b358-b9beae545cb3SPL set ID 1e6dc9ae-1c4c-42d9-87aa-c315ecc51b56RxCUI 1928686, 1928689, 2118739, 2118741, 2693088, 2693092, 2693094, 2693095, 2693096, 2693097, 2711637, 2711638UNII 089658A12D
- Pharmacologic class
- Interleukin-23 Antagonist
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
N457894065002followed by a unit qualifier and the quantityPackage 57894-0650-02. 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 .
Indications (excerpt from the label)
TREMFYA is an interleukin-23 antagonist indicated for the treatment of: adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with moderate-to-severe plaque psoriasis and who are candidates for systemic therapy or phototherapy. ( 1.1 ) adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with active psoriatic arthritis. ( 1.2 ) adults with moderately to severely active ulcerative colitis. ( 1.3 ) adults with moderately to severely active Crohn's disease. ( 1.4 ) 1.1 Plaque Psoriasis TREMFYA is indicated for the treatment of adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with moderate-to-sever…
Excerpt only. Read the full label for complete information.
About NDC 57894-650
- What is NDC 57894-650?
- 57894-650 is the product NDC for Tremfya (guselkumab), Guselkumab 200 mg/20mL injection, 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?
- Tremfya (Guselkumab).
- What is the active ingredient?
- Guselkumab.
- 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 Tremfya?
- 2 other product NDCs are listed under this name. See all Tremfya NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tremfya products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tremfyaguselkumab | Guselkumab 200 mg/2mL | InjectionSubcutaneous | Janssen Biotech, Inc. | 57894-651 | 57894-0651-0257894-0651-0457894-0651-22+1 more |
| Tremfyaguselkumab | Guselkumab 100 mg/mL | InjectionSubcutaneous | Janssen Biotech, Inc. | 57894-640 | 57894-0640-0157894-0640-0457894-0640-06+2 more |
Other NDCs under BLA 761061
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 |
|---|---|---|---|---|
| Tremfyaguselkumab | Guselkumab 100 mg/mL | InjectionSubcutaneous | Janssen Biotech, Inc. | 57894-640 |
| Tremfyaguselkumab | Guselkumab 200 mg/2mL | InjectionSubcutaneous | Janssen Biotech, Inc. | 57894-651 |