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YESINTEK

ustekinumab · Injection, Solution

Prescription Biologic BLA
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
YESINTEK
Generic name
ustekinumab
Dosage form
Injection, Solution
Route
Subcutaneous
Marketing category
BLA · BLA
Labeler
Biocon Biologics Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
3
Packages
3
Data completeness
52% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Ustekinumab 45 mg/.5mL 2700669 View
Ustekinumab 90 mg/mL 2700669 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Injection, Solution
Route of administration
Subcutaneous
Presentations
6

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Interleukin-12 Antagonist [EPC] EPC All 14 members
Interleukin-12 Antagonists [MoA] MoA All 14 members
Interleukin-23 Antagonist [EPC] EPC All 17 members
Interleukin-23 Antagonists [MoA] MoA All 17 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
761406
Application type
BLA · Biologics License Application
Approval date
November 29, 2024
Sponsor
BIOCON BIOLOGICS INC
Products on application
2
Submissions recorded
4
Products approved under application 761406.
Product Trade name Form Strength Ingredient Status TE Flags
761406-001 YESINTEK INJECTABLE USTEKINUMAB-KFCE Prescription —
761406-002 YESINTEK INJECTABLE USTEKINUMAB-KFCE Prescription —

Approval history

Source: Drugs@FDA
Most recent submissions on application 761406.
Type No. Action Status Date Review
Supplement 2 Efficacy Approved August 14, 2026 Standard
Supplement 1 Approved January 7, 2026 —
Original application 2 Approved April 30, 2025 Standard
Original application 1 Type 2 - New Active Ingredient Approved November 29, 2024 Standard

Review documents

  • 0 · Supplement · August 18, 2026
  • 0 · Supplement · August 18, 2026
  • 0 · Supplement · August 18, 2026
  • 0 · Original application · January 8, 2026
  • 0 · Supplement · January 8, 2026
  • 0 · Original application · June 30, 2025
  • 0 · Original application · June 30, 2025
  • 0 · Original application · May 5, 2025
  • 0 · Original application · April 30, 2025
  • 0 · Original application · December 2, 2024
  • 0 · Original application · November 29, 2024

Adverse event reports

Source: openFDA FAERS
102,265
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: USTEKINUMAB. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
83257-023-41 83257-023 Biocon Biologics Inc. 1 SYRINGE in 1 CARTON (83257-023-41) / .5 mL in 1 SYRINGE February 22, 2025
83257-024-11 83257-024 Biocon Biologics Inc. 1 VIAL, SINGLE-USE in 1 CARTON (83257-024-11) / .5 mL in 1 VIAL, SINGLE-USE February 22, 2025
83257-025-41 83257-025 Biocon Biologics Inc. 1 SYRINGE in 1 CARTON (83257-025-41) / 1 mL in 1 SYRINGE February 22, 2025
83257-023 83257-023 Biocon Biologics Inc. — February 22, 2025
83257-024 83257-024 Biocon Biologics Inc. — February 22, 2025
83257-025 83257-025 Biocon Biologics Inc. — February 22, 2025

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
FAERS FDA Adverse event report counts
Purple Book FDA Biologic licence classification

Generated September 25, 2026 · 9 sections on this page.