UZEDY

Orange BookUNIISPLATC N05AX08

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerTeva Pharmaceuticals USA, Inc.

CountryUS (United States)

ATC codeN05AX08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5175985010
1 SYRINGE, GLASS in 1 CARTON (51759-850-10) / .56 mL in 1 SYRINGE, GLASS
ndc11
5175985011
1 SYRINGE, GLASS in 1 CARTON (51759-850-11) / .56 mL in 1 SYRINGE, GLASS

Annotations

UNII (FDA Substance ID)

L6UH7ZF8HC

RISPERIDONE

RxCUI 35636

Orange Book

N213586

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "L6UH7ZF8HC",
    "rxcui": "35636",
    "inchikey": "RAPZEAPATHNIPO-UHFFFAOYSA-N",
    "display_name": "RISPERIDONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "734eb776-4be0-4808-834b-0d8b0f9e021e": {
      "match": "brand_token",
      "title": "UZEDY (RISPERIDONE) INJECTION, SUSPENSION, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA, INC.]",
      "spl_version": "7",
      "published_date": "2025-11-17"
    }
  },
  "productid": "51759-850_b2a4d0bf-6512-4755-8225-ce2716bca07b",
  "productndc": "51759-850",
  "dosage_form": "INJECTION, SUSPENSION, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "213586",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "50MG/0.14ML (50MG/0.14ML)",
        "product_no": "001",
        "approval_date": "Apr 28, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "75MG/0.21ML (75MG/0.21ML)",
        "product_no": "002",
        "approval_date": "Apr 28, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "100MG/0.28ML (100MG/0.28ML)",
        "product_no": "003",
        "approval_date": "Apr 28, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "125MG/0.35ML (125MG/0.35ML)",
        "product_no": "004",
        "approval_date": "Apr 28, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "150MG/0.42ML (150MG/0.42ML)",
        "product_no": "005",
        "approval_date": "Apr 28, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "200MG/0.56ML (200MG/0.56ML)",
        "product_no": "006",
        "approval_date": "Apr 28, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "250MG/0.7ML (250MG/0.7ML)",
        "product_no": "007",
        "approval_date": "Apr 28, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "RISPERIDONE",
  "proprietary_name": "UZEDY",
  "active_ingred_unit": "mg/.56mL",
  "application_number": "NDA213586",
  "marketing_category": "NDA",
  "nonproprietary_name": "risperidone",
  "start_marketing_date": "20230501",
  "active_numerator_strength": "200"
}

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