yesintek

Generic: ustekinumab

Labeler: biocon biologics inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name yesintek
Generic Name ustekinumab
Labeler biocon biologics inc.
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

ustekinumab 90 mg/mL

Manufacturer
Biocon Biologics Inc.

Identifiers & Regulatory

Product NDC 83257-025
Product ID 83257-025_c3b2dc18-4456-908e-f957-6bc50d22b925
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761406
Listing Expiration 2027-12-31
Marketing Start 2025-02-22

Pharmacologic Class

Established (EPC)
interleukin-12 antagonist [epc] interleukin-23 antagonist [epc]
Mechanism of Action
interleukin-12 antagonists [moa] interleukin-23 antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83257025
Hyphenated Format 83257-025

Supplemental Identifiers

RxCUI
2705581 2705588 2705592 2705597 2705599 2705600 2705601 2705603
UNII
FU77B4U5Z0
NUI
N0000192797 N0000192796 N0000192799 N0000192798

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name yesintek (source: ndc)
Generic Name ustekinumab (source: ndc)
Application Number BLA761406 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 90 mg/mL
source: ndc
Packaging
  • 1 SYRINGE in 1 CARTON (83257-025-41) / 1 mL in 1 SYRINGE
source: ndc

Packages (1)

83257-025-41 1 SYRINGE in 1 CARTON (83257-025-41) / 1 mL in 1 SYRINGE

Ingredients (1)

ustekinumab (90 mg/mL)

Linked Drug Pages (1)

YESINTEK ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "c3b2dc18-4456-908e-f957-6bc50d22b925", "openfda": {"nui": ["N0000192797", "N0000192796", "N0000192799", "N0000192798"], "unii": ["FU77B4U5Z0"], "rxcui": ["2705581", "2705588", "2705592", "2705597", "2705599", "2705600", "2705601", "2705603"], "spl_set_id": ["12a75613-ee33-d30a-215b-2a51cfa19b00"], "pharm_class_epc": ["Interleukin-12 Antagonist [EPC]", "Interleukin-23 Antagonist [EPC]"], "pharm_class_moa": ["Interleukin-12 Antagonists [MoA]", "Interleukin-23 Antagonists [MoA]"], "manufacturer_name": ["Biocon Biologics Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 CARTON (83257-025-41)  / 1 mL in 1 SYRINGE", "package_ndc": "83257-025-41", "marketing_start_date": "20250222"}], "brand_name": "YESINTEK", "product_id": "83257-025_c3b2dc18-4456-908e-f957-6bc50d22b925", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Interleukin-12 Antagonist [EPC]", "Interleukin-12 Antagonists [MoA]", "Interleukin-23 Antagonist [EPC]", "Interleukin-23 Antagonists [MoA]"], "product_ndc": "83257-025", "generic_name": "ustekinumab", "labeler_name": "Biocon Biologics Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "YESINTEK", "active_ingredients": [{"name": "USTEKINUMAB", "strength": "90 mg/mL"}], "application_number": "BLA761406", "marketing_category": "BLA", "marketing_start_date": "20250222", "listing_expiration_date": "20271231"}