Lurasidone Hydrochloride

Orange BookUNIISPLATC N05AE05

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

Identification

ManufacturerHeritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Inc.

CountryUS (United States)

ATC codeN05AE05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
2315589101
100 TABLET, FILM COATED in 1 BOTTLE (23155-891-01)
ndc11
2315589103
30 TABLET, FILM COATED in 1 BOTTLE (23155-891-03)
ndc11
2315589105
500 TABLET, FILM COATED in 1 BOTTLE (23155-891-05)
ndc11
2315589110
1000 TABLET, FILM COATED in 1 BOTTLE (23155-891-10)
ndc11
2315589118
20000 TABLET, FILM COATED in 1 CONTAINER (23155-891-18)

Annotations

UNII (FDA Substance ID)

O0P4I5851I

LURASIDONE HYDROCHLORIDE

RxCUI 1040027

Orange Book

A208058

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": "23155-891_0827fe43-e438-44c3-9962-7491d04b445d",
  "productndc": "23155-891",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "208058",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Sep 4, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "002",
        "approval_date": "Sep 4, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "60MG",
        "product_no": "003",
        "approval_date": "Sep 4, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "80MG",
        "product_no": "004",
        "approval_date": "Sep 4, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "120MG",
        "product_no": "005",
        "approval_date": "Feb 28, 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": "ANDA208058",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lurasidone Hydrochloride",
  "start_marketing_date": "20231019",
  "active_numerator_strength": "120"
}

Related drugs

Other records sharing ATC code N05AE05.

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