Prescription drug · BLA
Pyzchiva (ustekinumab-ttwe) NDC 83457-651
Ustekinumab 45 mg/.5mL · Injection, Solution · Subcutaneous · Cordavis Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83457-651-01 | 83457065101 | 1 SYRINGE in 1 CARTON (83457-651-01) / .5 mL in 1 SYRINGEMarketed from May 1, 2025 | |
| 83457-651-96 | 83457065196 | 1 SYRINGE in 1 CARTON (83457-651-96) / .5 mL in 1 SYRINGEMarketed from Aug 14, 2025 |
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)
- Pyzchiva
- Generic name (nonproprietary)
- ustekinumab-ttwe
- Active ingredients
- Ustekinumab — 45 mg/.5mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Cordavis Limited
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761373
- Marketing start
- Listing expires
- Other FDA classes
- Interleukin-12 Antagonists (Mechanism)Interleukin-23 Antagonists (Mechanism)
- Identifiers
- Product ID 83457-651_d56ad790-9d1a-46e3-b0c4-7e2c7c172157SPL ID d56ad790-9d1a-46e3-b0c4-7e2c7c172157SPL set ID f356501d-1347-4557-a252-c2d9f1b2dcb2RxCUI 2705568, 2705573, 2705575, 2705576, 2720512, 2720516, 2721430, 2721431UNII 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
N483457065101followed by a unit qualifier and the quantityPackage 83457-0651-01. 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)
PYZCHIVA 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 (PsO), who are candidates for phototherapy or systemic therapy. ( 1.1 ) active psoriatic arthritis (PsA). ( 1.2 ) 1.1 Plaque Psoriasis (PsO) PYZCHIVA 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 761373
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-Ttwe | Ustekinumab 45 mg/.5mL | Injection, SolutionSubcutaneous | Quallent Pharmaceuticals Health LLC | 82009-161 |
| Ustekinumab-Ttwe | Ustekinumab 45 mg/.5mL | Injection, SolutionSubcutaneous | Quallent Pharmaceuticals Health LLC | 82009-160 |
| Ustekinumab-Ttwe | Ustekinumab 90 mg/mL | Injection, SolutionSubcutaneous | Quallent Pharmaceuticals Health LLC | 82009-162 |
| Pyzchivaustekinumab-ttwe | Ustekinumab 90 mg/mL | Injection, SolutionSubcutaneous | SANDOZ INC | 61314-652 |
| Pyzchivaustekinumab-ttwe | Ustekinumab 45 mg/.5mL | Injection, SolutionSubcutaneous | SANDOZ INC | 61314-651 |
| Pyzchivaustekinumab-ttwe | Ustekinumab 90 mg/mL | Injection, SolutionSubcutaneous | Cordavis Limited | 83457-652 |