Prescription drug · BLA
Ustekinumab-Ttwe NDC 82009-161
Ustekinumab 45 mg/.5mL · Injection, Solution · Subcutaneous · Quallent Pharmaceuticals Health LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82009-161-94 | 8200901619482009016194 | .5 mL in 1 VIAL (82009-161-94)Marketed from Feb 15, 2026 |
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)
- Ustekinumab-Ttwe
- Generic name (nonproprietary)
- ustekinumab-ttwe
- Active ingredients
- Ustekinumab — 45 mg/.5mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Quallent Pharmaceuticals Health LLCNDC labeler code 82009
- 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 82009-161_cb6d8d30-9458-42ed-8aee-2aae13f4760bSPL ID cb6d8d30-9458-42ed-8aee-2aae13f4760bSPL set ID 2b34392a-ecf6-41bd-8706-d4e9f0b25da8RxCUI 2705557, 2705568, 2705575, 2713885UNII 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
N482009016194followed by a unit qualifier and the quantityPackage 82009-0161-94. 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)
USTEKINUMAB-TTWE 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) USTEKINUMAB-TTWE is indicated for the treatment of adults and pediatric patients 6 years of age an…
Excerpt only. Read the full label for complete information.
About NDC 82009-161
- What is NDC 82009-161?
- 82009-161 is the product NDC for Ustekinumab-Ttwe, Ustekinumab 45 mg/.5mL injection, solution, listed with the FDA by Quallent Pharmaceuticals Health LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ustekinumab-Ttwe.
- What is the active ingredient?
- Ustekinumab.
- Who is the labeler?
- Quallent Pharmaceuticals Health LLC, NDC labeler code 82009. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ustekinumab-Ttwe?
- 3 other product NDCs are listed under this name. See all Ustekinumab-Ttwe NDCs.
- Is there a related HCPCS / J-code?
- Yes: J3357, Injection, ustekinumab, for subcutaneous injection, 1 mg. See Billing references above.
Related NDCs: other Ustekinumab-Ttwe products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ustekinumab-Ttwe | Ustekinumab 45 mg/.5mL | Injection, SolutionSubcutaneous | Quallent Pharmaceuticals Health LLC | 82009-160 | 82009-0160-11 |
| Ustekinumab-Ttwe | Ustekinumab 90 mg/mL | Injection, SolutionSubcutaneous | Quallent Pharmaceuticals Health LLC | 82009-162 | 82009-0162-11 |
| Ustekinumab-Ttwe | Ustekinumab 130 mg/26mL | Injection, SolutionIntravenous | Quallent Pharmaceuticals Health LLC | 82009-163 | 82009-0163-94 |
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 |
|---|---|---|---|---|
| Pyzchivaustekinumab-ttwe | Ustekinumab 45 mg/.5mL | Injection, SolutionSubcutaneous | SANDOZ INC | 61314-651 |
| Pyzchivaustekinumab-ttwe | Ustekinumab 90 mg/mL | Injection, SolutionSubcutaneous | SANDOZ INC | 61314-652 |
| Pyzchivaustekinumab-ttwe | Ustekinumab 45 mg/.5mL | Injection, SolutionSubcutaneous | Cordavis Limited | 83457-651 |
| Pyzchivaustekinumab-ttwe | Ustekinumab 90 mg/mL | Injection, SolutionSubcutaneous | Cordavis Limited | 83457-652 |
| 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 |