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United States · US · US:70121-2626_1109da94-12c2-4378-b9fb-74f94382b90a

Risperidone

Orange BookSPL

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7012126265
    1 KIT in 1 CARTON (70121-2626-5) * 2 mL in 1 SYRINGE (70121-2624-2) * 2 mL in 1 VIAL (70121-1351-1)

Annotations

Orange Book
A218586
ABABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": "INTRAMUSCULAR",
  "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": "70121-2626_1109da94-12c2-4378-b9fb-74f94382b90a",
  "productndc": "70121-2626",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "218586",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG/VIAL",
        "product_no": "001",
        "approval_date": "Sep 2, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG/VIAL",
        "product_no": "002",
        "approval_date": "Sep 2, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "37.5MG/VIAL",
        "product_no": "003",
        "approval_date": "Sep 2, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG/VIAL",
        "product_no": "004",
        "approval_date": "Sep 2, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Risperidone",
  "active_ingred_unit": null,
  "application_number": "ANDA218586",
  "marketing_category": "ANDA",
  "nonproprietary_name": "risperidone",
  "start_marketing_date": "20250908",
  "active_numerator_strength": null
}

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