Prescription drug · BLA
Stelara (ustekinumab) NDC 57894-054
Ustekinumab 130 mg/26mL · Solution · Intravenous · Janssen Biotech, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57894-054-16 | 57894005416 | 1 VIAL, SINGLE-USE in 1 BOX (57894-054-16) / 26 mL in 1 VIAL, SINGLE-USEMarketed from May 1, 2017 · Sample package | |
| 57894-054-27 | 57894005427 | 1 VIAL, SINGLE-USE in 1 BOX (57894-054-27) / 26 mL in 1 VIAL, SINGLE-USEMarketed from Sep 23, 2016 |
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)
- Stelara
- Generic name (nonproprietary)
- ustekinumab
- Active ingredients
- Ustekinumab — 130 mg/26mL
- Dosage form
- Solution
- Route
- Intravenous
- Labeler
- Janssen Biotech, Inc.
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761044
- Marketing start
- Listing expires
- Other FDA classes
- Interleukin-12 Antagonists (Mechanism)Interleukin-23 Antagonists (Mechanism)
- Identifiers
- Product ID 57894-054_30a2caf3-0c87-47a6-b087-25028ff6f8c0SPL ID 30a2caf3-0c87-47a6-b087-25028ff6f8c0SPL set ID c77a9664-e3bb-4023-b400-127aa53bca2bRxCUI 853350, 853354, 853355, 853356, 1654077, 1654079, 1811255, 1811257UNII FU77B4U5Z0UPC 0357894060031, 0357894054276
- Pharmacologic class
- Interleukin-12 Antagonist; 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
N457894005416followed by a unit qualifier and the quantityPackage 57894-0054-16. 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)
STELARA is a human interleukin-12 and -23 antagonist indicated for the treatment of: Moderate to severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy. ( 1.1 ) Active psoriatic arthritis in adults and pediatric patients 6 years of age and older. ( 1.2 ) Moderately to severely active Crohn's disease in adults and pediatric patients 2 years of age and older. ( 1.3 ) Moderately to severely active ulcerative colitis in adults and pediatric patients 2 years of age and older. ( 1.4 ) 1.1 Plaque Psoriasis (PsO) STELARA is indicated for the treatment of adults and pediatric patients 6 years of age and older with mode…
Excerpt only. Read the full label for complete information.
Other NDCs under BLA 761044
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 |
|---|---|---|---|---|
| ustekinumab | Ustekinumab 130 mg/26mL | SolutionIntravenous | Janssen Biotech, Inc. | 57894-444 |