Prescription drug · BLA
Yesintek (Ustekinumab) NDC 83257-023
Ustekinumab 45 mg/.5mL · Injection, Solution · Subcutaneous · Biocon Biologics Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83257-023-41 | 8325700234183257002341 | 1 SYRINGE in 1 CARTON (83257-023-41) / .5 mL in 1 SYRINGEMarketed from Feb 22, 2025 · Sample package |
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)
- Yesintek
- Generic name (nonproprietary)
- ustekinumab
- Active ingredients
- Ustekinumab — 45 mg/.5mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Biocon Biologics Inc.NDC labeler code 83257
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761406
- Marketing start
- Listing expires
- Other FDA classes
- Interleukin-12 Antagonists (Mechanism)Interleukin-23 Antagonists (Mechanism)
- Identifiers
- Product ID 83257-023_326c6710-ed89-ec68-64de-c829281376d4SPL ID 326c6710-ed89-ec68-64de-c829281376d4
- 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
N483257002341followed by a unit qualifier and the quantityPackage 83257-0023-41. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 83257-023
- What is NDC 83257-023?
- 83257-023 is the product NDC for Yesintek (ustekinumab), Ustekinumab 45 mg/.5mL injection, solution, listed with the FDA by Biocon Biologics Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Yesintek (Ustekinumab).
- What is the active ingredient?
- Ustekinumab.
- Who is the labeler?
- Biocon Biologics Inc., NDC labeler code 83257. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Yesintek?
- 3 other product NDCs are listed under this name. See all Yesintek NDCs.
- Is there a related HCPCS / J-code?
- Yes: J3357, Injection, ustekinumab, for subcutaneous injection, 1 mg. See Billing references above.
Related NDCs: other Yesintek products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Yesintekustekinumab | Ustekinumab 45 mg/.5mL | Injection, SolutionSubcutaneous | Biocon Biologics Inc. | 83257-024 | 83257-0024-11 |
| Yesintekustekinumab | Ustekinumab 90 mg/mL | Injection, SolutionSubcutaneous | Biocon Biologics Inc. | 83257-025 | 83257-0025-41 |
| Yesintekustekinumab | Ustekinumab 130 mg/26mL | SolutionIntravenous | Biocon Biologics Inc. | 83257-026 | 83257-0026-11 |
Other NDCs under BLA 761406
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 |
|---|---|---|---|---|
| Yesintekustekinumab | Ustekinumab 45 mg/.5mL | Injection, SolutionSubcutaneous | Biocon Biologics Inc. | 83257-024 |
| Yesintekustekinumab | Ustekinumab 90 mg/mL | Injection, SolutionSubcutaneous | Biocon Biologics Inc. | 83257-025 |
| Yesintekustekinumab | Ustekinumab 130 mg/26mL | SolutionIntravenous | Biocon Biologics Inc. | 83257-026 |