Lurasidone hydrochloride

Orange BookUNIISPLATC N05AE05

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

Identification

ManufacturerZydus Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeN05AE05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
6838296501
100 TABLET, COATED in 1 BOTTLE (68382-965-01)
ndc11
6838296505
500 TABLET, COATED in 1 BOTTLE (68382-965-05)
ndc11
6838296506
30 TABLET, COATED in 1 BOTTLE (68382-965-06)
ndc11
6838296516
90 TABLET, COATED in 1 BOTTLE (68382-965-16)
ndc11
6838296577
100 BLISTER PACK in 1 CARTON (68382-965-77) / 1 TABLET, COATED in 1 BLISTER PACK (68382-965-30)

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": "68382-965_4583ae02-09cb-4dd4-b5e7-b3074f3b95aa",
  "productndc": "68382-965",
  "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": "20"
}

Related drugs

Other records sharing ATC code N05AE05.

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