Prescription drug · BLA
Starjemza (ustekinumab-hmny) NDC 0143-9169
Ustekinumab 45 mg/.5mL · Injection · Subcutaneous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0143-9169-01 | 00143916901 | .5 mL in 1 VIAL (0143-9169-01)Marketed from Oct 27, 2025 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Starjemza
- Generic name (nonproprietary)
- ustekinumab-hmny
- Active ingredients
- Ustekinumab — 45 mg/.5mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761419
- Marketing start
- Listing expires
- Other FDA classes
- Interleukin-12 Antagonists (Mechanism)Interleukin-23 Antagonists (Mechanism)
- Identifiers
- Product ID 0143-9169_4f0ed512-9cd1-4280-af36-37ed3090d632SPL ID 4f0ed512-9cd1-4280-af36-37ed3090d632SPL set ID 8b72aa27-82cc-4c1b-be43-8b50e5e3d737RxCUI 2725087, 2725094, 2725099, 2725100, 2725102, 2725106, 2725111, 2725114UNII FU77B4U5Z0
- 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 codeMed-Code curated
J3357 — Injection, ustekinumab, for subcutaneous injection, 1 mg
Billing unit: 1 mg. Units on the claim = dose given ÷ 1 mg.
J3357 covers the subcutaneous formulation. The intravenous formulation has a separate code (J3358). Ustekinumab biosimilars are listed under their own names.
- 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
N400143916901followed by a unit qualifier and the quantityPackage 00143-9169-01. 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 .
Indications (excerpt from the label)
STARJEMZA is a human interleukin-12 and -23 antagonist indicated for the treatment of: Adult patients with: moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. ( 1.1 ) active psoriatic arthritis (PsA) . ( 1.2 ) moderately to severely active Crohn’s disease (CD) . ( 1.3 ) moderately to severely active ulcerative colitis. ( 1.4 ) Pediatric patients 6 years and older with: moderate to severe plaque psoriasis , who are candidates for phototherapy or systemic therapy. ( 1.1 ) active psoriatic arthritis (PsA) . ( 1.2 ) 1.1 Plaque Psoriasis (PsO) STARJEMZA is indicated for the treatment of adults and pediatric patients 6 years of age and older with mod…
Excerpt only. Read the full label for complete information.
Other NDCs under BLA 761419
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 |
|---|---|---|---|---|
| Starjemzaustekinumab-hmny | Ustekinumab 45 mg/.5mL | InjectionSubcutaneous | Hikma Pharmaceuticals USA Inc. | 0143-9168 |
| Starjemzaustekinumab-hmny | Ustekinumab 90 mg/mL | InjectionSubcutaneous | Hikma Pharmaceuticals USA Inc. | 0143-9170 |
| Starjemzaustekinumab-hmny | Ustekinumab 130 mg/26mL | InjectionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9171 |