LURASIDONE HYDROCHLORIDE

Orange BookUNIISPLATC N05AE05

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

Identification

ManufacturerAurobindo Pharma Limited

CountryUS (United States)

ATC codeN05AE05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
6586295705
500 TABLET in 1 BOTTLE (65862-957-05)
ndc11
6586295730
30 TABLET in 1 BOTTLE (65862-957-30)
ndc11
6586295790
90 TABLET in 1 BOTTLE (65862-957-90)

Annotations

UNII (FDA Substance ID)

O0P4I5851I

LURASIDONE HYDROCHLORIDE

RxCUI 1040027

Orange Book

A208045

ABABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "O0P4I5851I",
    "rxcui": "1040027",
    "inchikey": "NEKCRUIRPWNMLK-SCIYSFAVSA-N",
    "display_name": "LURASIDONE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "2b07a830-93ba-427a-95fc-5138a6309f1e": {
      "match": "brand_token",
      "title": "LURASIDONE HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]",
      "spl_version": "4",
      "published_date": "2026-04-29"
    }
  },
  "productid": "65862-957_b73e1972-e96d-4463-ad39-f7bed99466e9",
  "productndc": "65862-957",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "208045",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Mar 10, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "002",
        "approval_date": "Mar 10, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "60MG",
        "product_no": "003",
        "approval_date": "Mar 10, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "80MG",
        "product_no": "004",
        "approval_date": "Mar 10, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "120MG",
        "product_no": "005",
        "approval_date": "Mar 10, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LURASIDONE HYDROCHLORIDE",
  "proprietary_name": "LURASIDONE HYDROCHLORIDE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA208045",
  "marketing_category": "ANDA",
  "nonproprietary_name": "LURASIDONE HYDROCHLORIDE",
  "start_marketing_date": "20230310",
  "active_numerator_strength": "120"
}

Related drugs

Other records sharing ATC code N05AE05.

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