ustekinumab-aekn

Generic: ustekinumab-aekn

Labeler: teva pharmaceuticals usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name ustekinumab-aekn
Generic Name ustekinumab-aekn
Labeler teva pharmaceuticals usa, inc.
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

ustekinumab-aekn 45 mg/.5mL

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 51759-413
Product ID 51759-413_ce170247-5614-44bc-88e0-89f515d9d8be
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761343
Listing Expiration 2027-12-31
Marketing Start 2025-12-23

Pharmacologic Class

Classes
interleukin-12 antagonist [epc] interleukin-12 antagonists [moa] interleukin-23 antagonist [epc] interleukin-23 antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51759413
Hyphenated Format 51759-413

Supplemental Identifiers

RxCUI
2705393 2705400
UNII
FU77B4U5Z0

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 ustekinumab-aekn (source: ndc)
Generic Name ustekinumab-aekn (source: ndc)
Application Number BLA761343 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 45 mg/.5mL
source: ndc
Packaging
  • 1 TRAY in 1 CARTON (51759-413-32) / 1 SYRINGE, GLASS in 1 TRAY / .5 mL in 1 SYRINGE, GLASS
source: ndc

Packages (1)

51759-413-32 1 TRAY in 1 CARTON (51759-413-32) / 1 SYRINGE, GLASS in 1 TRAY / .5 mL in 1 SYRINGE, GLASS

Ingredients (1)

ustekinumab-aekn (45 mg/.5mL)

Linked Drug Pages (1)

Ustekinumab-aekn ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "ce170247-5614-44bc-88e0-89f515d9d8be", "openfda": {"unii": ["FU77B4U5Z0"], "rxcui": ["2705393", "2705400"], "spl_set_id": ["052a3fb2-21c3-4c4e-a01e-afdd1accd1cd"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 TRAY in 1 CARTON (51759-413-32)  / 1 SYRINGE, GLASS in 1 TRAY / .5 mL in 1 SYRINGE, GLASS", "package_ndc": "51759-413-32", "marketing_start_date": "20251223"}], "brand_name": "Ustekinumab-aekn", "product_id": "51759-413_ce170247-5614-44bc-88e0-89f515d9d8be", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Interleukin-12 Antagonist [EPC]", "Interleukin-12 Antagonists [MoA]", "Interleukin-23 Antagonist [EPC]", "Interleukin-23 Antagonists [MoA]"], "product_ndc": "51759-413", "generic_name": "ustekinumab-aekn", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ustekinumab-aekn", "active_ingredients": [{"name": "USTEKINUMAB-AEKN", "strength": "45 mg/.5mL"}], "application_number": "BLA761343", "marketing_category": "BLA", "marketing_start_date": "20251223", "listing_expiration_date": "20271231"}