risperidone

Orange BookSPL

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

Identification

ManufacturerLupin Pharmaceuticals, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7074827013
1 KIT in 1 BOX (70748-270-13) * 2 mL in 1 VIAL (70748-449-11) * 2 mL in 1 SYRINGE (70748-448-01)

Annotations

Orange Book

A211220

ABABAB

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": "70748-270_295a5259-e2b6-4c5c-aacb-6a85a8c4babb",
  "productndc": "70748-270",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "211220",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG/VIAL",
        "product_no": "001",
        "approval_date": "Sep 2, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "37.5MG/VIAL",
        "product_no": "002",
        "approval_date": "Sep 2, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG/VIAL",
        "product_no": "003",
        "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": "ANDA211220",
  "marketing_category": "ANDA",
  "nonproprietary_name": "risperidone",
  "start_marketing_date": "20251017",
  "active_numerator_strength": null
}

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