Lurasidone hydrochloride

Orange BookUNIISPLATC N05AE05

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

Identification

ManufacturerZydus Lifesciences Limited

CountryUS (United States)

ATC codeN05AE05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
7077117371
100 TABLET, COATED in 1 BOTTLE (70771-1737-1)
ndc11
7077117373
30 TABLET, COATED in 1 BOTTLE (70771-1737-3)
ndc11
7077117374
10 BLISTER PACK in 1 CARTON (70771-1737-4) / 10 TABLET, COATED in 1 BLISTER PACK (70771-1737-2)
ndc11
7077117375
500 TABLET, COATED in 1 BOTTLE (70771-1737-5)
ndc11
7077117379
90 TABLET, COATED in 1 BOTTLE (70771-1737-9)

Annotations

UNII (FDA Substance ID)

O0P4I5851I

LURASIDONE HYDROCHLORIDE

RxCUI 1040027

Orange Book

A208052

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": "70771-1737_b82674a0-84e9-4431-9041-e5c360bbdaca",
  "productndc": "70771-1737",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "208052",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Mar 19, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "002",
        "approval_date": "Mar 19, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "60MG",
        "product_no": "003",
        "approval_date": "Mar 19, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "80MG",
        "product_no": "004",
        "approval_date": "Mar 19, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "120MG",
        "product_no": "005",
        "approval_date": "Mar 19, 2019"
      }
    ],
    "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": "ANDA208052",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lurasidone hydrochloride",
  "start_marketing_date": "20230201",
  "active_numerator_strength": "80"
}

Related drugs

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