uzedy

Generic: risperidone

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

Drug Facts

Product Profile

Brand Name uzedy
Generic Name risperidone
Labeler teva pharmaceuticals usa, inc.
Dosage Form INJECTION, SUSPENSION, EXTENDED RELEASE
Routes
SUBCUTANEOUS
Active Ingredients

risperidone 50 mg/.14mL

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 51759-305
Product ID 51759-305_b2a4d0bf-6512-4755-8225-ce2716bca07b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA213586
Listing Expiration 2026-12-31
Marketing Start 2023-05-01

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51759305
Hyphenated Format 51759-305

Supplemental Identifiers

RxCUI
2636033 2636039 2636041 2636042 2636043 2636044 2636045 2636046 2636047 2636048 2636049 2636050 2636051 2636052
UNII
L6UH7ZF8HC
NUI
N0000175430

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 uzedy (source: ndc)
Generic Name risperidone (source: ndc)
Application Number NDA213586 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/.14mL
source: ndc
Packaging
  • 1 SYRINGE, GLASS in 1 CARTON (51759-305-10) / .14 mL in 1 SYRINGE, GLASS
  • 1 SYRINGE, GLASS in 1 CARTON (51759-305-11) / .14 mL in 1 SYRINGE, GLASS
source: ndc

Packages (2)

51759-305-10 1 SYRINGE, GLASS in 1 CARTON (51759-305-10) / .14 mL in 1 SYRINGE, GLASS 51759-305-11 1 SYRINGE, GLASS in 1 CARTON (51759-305-11) / .14 mL in 1 SYRINGE, GLASS

Ingredients (1)

risperidone (50 mg/.14mL)

Linked Drug Pages (1)

UZEDY ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "b2a4d0bf-6512-4755-8225-ce2716bca07b", "openfda": {"nui": ["N0000175430"], "unii": ["L6UH7ZF8HC"], "rxcui": ["2636033", "2636039", "2636041", "2636042", "2636043", "2636044", "2636045", "2636046", "2636047", "2636048", "2636049", "2636050", "2636051", "2636052"], "spl_set_id": ["734eb776-4be0-4808-834b-0d8b0f9e021e"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE, GLASS in 1 CARTON (51759-305-10)  / .14 mL in 1 SYRINGE, GLASS", "package_ndc": "51759-305-10", "marketing_start_date": "20230501"}, {"sample": true, "description": "1 SYRINGE, GLASS in 1 CARTON (51759-305-11)  / .14 mL in 1 SYRINGE, GLASS", "package_ndc": "51759-305-11", "marketing_start_date": "20230501"}], "brand_name": "UZEDY", "product_id": "51759-305_b2a4d0bf-6512-4755-8225-ce2716bca07b", "dosage_form": "INJECTION, SUSPENSION, EXTENDED RELEASE", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "51759-305", "generic_name": "risperidone", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "UZEDY", "active_ingredients": [{"name": "RISPERIDONE", "strength": "50 mg/.14mL"}], "application_number": "NDA213586", "marketing_category": "NDA", "marketing_start_date": "20230501", "listing_expiration_date": "20261231"}