selarsdi

Generic: ustekinumab-aekn

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

Drug Facts

Product Profile

Brand Name selarsdi
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 51759-505
Product ID 51759-505_640e5a4e-13d5-4c59-8f37-41cd31fa4fc0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761343
Listing Expiration 2026-12-31
Marketing Start 2025-03-12

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 51759505
Hyphenated Format 51759-505

Supplemental Identifiers

RxCUI
2705382 2705389 2705393 2705398 2705400 2705401 2726116 2726118
UNII
FU77B4U5Z0

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 selarsdi (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 VIAL in 1 CARTON (51759-505-13) / .5 mL in 1 VIAL
  • 1 TRAY in 1 CARTON (51759-505-32) / 1 SYRINGE, GLASS in 1 TRAY / .5 mL in 1 SYRINGE, GLASS
source: ndc

Packages (2)

51759-505-13 1 VIAL in 1 CARTON (51759-505-13) / .5 mL in 1 VIAL 51759-505-32 1 TRAY in 1 CARTON (51759-505-32) / 1 SYRINGE, GLASS in 1 TRAY / .5 mL in 1 SYRINGE, GLASS

Ingredients (1)

ustekinumab-aekn (45 mg/.5mL)

Linked Drug Pages (1)

Selarsdi ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "640e5a4e-13d5-4c59-8f37-41cd31fa4fc0", "openfda": {"unii": ["FU77B4U5Z0"], "rxcui": ["2705382", "2705389", "2705393", "2705398", "2705400", "2705401", "2726116", "2726118"], "spl_set_id": ["87f75b59-e48b-47c7-a4c0-5fe5965660e7"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (51759-505-13)  / .5 mL in 1 VIAL", "package_ndc": "51759-505-13", "marketing_start_date": "20251016"}, {"sample": false, "description": "1 TRAY in 1 CARTON (51759-505-32)  / 1 SYRINGE, GLASS in 1 TRAY / .5 mL in 1 SYRINGE, GLASS", "package_ndc": "51759-505-32", "marketing_start_date": "20250312"}], "brand_name": "Selarsdi", "product_id": "51759-505_640e5a4e-13d5-4c59-8f37-41cd31fa4fc0", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Interleukin-12 Antagonist [EPC]", "Interleukin-12 Antagonists [MoA]", "Interleukin-23 Antagonist [EPC]", "Interleukin-23 Antagonists [MoA]"], "product_ndc": "51759-505", "generic_name": "ustekinumab-aekn", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Selarsdi", "active_ingredients": [{"name": "USTEKINUMAB-AEKN", "strength": "45 mg/.5mL"}], "application_number": "BLA761343", "marketing_category": "BLA", "marketing_start_date": "20250312", "listing_expiration_date": "20261231"}