Risperidone

Orange BookSPL

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

Identification

ManufacturerTeva Pharmaceuticals, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0480145308
1 KIT in 1 CARTON (0480-1453-08) * 2 mL in 1 VIAL (0480-9735-01) * 2 mL in 1 SYRINGE (0480-1200-21)

Annotations

Orange Book

A214068

ABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "43aa2a4f-1123-4f86-800b-9218882f7bcd": {
      "match": "brand_token",
      "title": "RISPERIDONE TABLET [SOLCO HEALTHCARE US, LLC]",
      "spl_version": "14",
      "published_date": "2026-05-26"
    }
  },
  "productid": "0480-1453_7cf4d36f-baab-4a9e-8a17-aeb0d6dd7918",
  "productndc": "0480-1453",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "214068",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG/VIAL",
        "product_no": "001",
        "approval_date": "Dec 5, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG/VIAL",
        "product_no": "002",
        "approval_date": "Dec 5, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "37.5MG/VIAL",
        "product_no": "003",
        "approval_date": "Dec 5, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG/VIAL",
        "product_no": "004",
        "approval_date": "Dec 5, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Risperidone",
  "active_ingred_unit": null,
  "application_number": "ANDA214068",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Risperidone",
  "start_marketing_date": "20231211",
  "active_numerator_strength": null
}

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