Lurasidone Hydrochloride

Orange BookUNIISPLATC N05AE05

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

Identification

ManufacturerCamber Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeN05AE05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
3172208405
500 TABLET, FILM COATED in 1 BOTTLE (31722-084-05)
ndc11
3172208430
30 TABLET, FILM COATED in 1 BOTTLE (31722-084-30)
ndc11
3172208490
90 TABLET, FILM COATED in 1 BOTTLE (31722-084-90)

Annotations

UNII (FDA Substance ID)

O0P4I5851I

LURASIDONE HYDROCHLORIDE

RxCUI 1040027

Orange Book

A218174

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": "31722-084_3a429e3e-35e3-c6bb-e063-6294a90ac9ee",
  "productndc": "31722-084",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "218174",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Aug 21, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "002",
        "approval_date": "Aug 21, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "60MG",
        "product_no": "003",
        "approval_date": "Aug 21, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "80MG",
        "product_no": "004",
        "approval_date": "Aug 21, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "120MG",
        "product_no": "005",
        "approval_date": "Aug 21, 2024"
      }
    ],
    "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": "ANDA218174",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lurasidone Hydrochloride",
  "start_marketing_date": "20240821",
  "active_numerator_strength": "120"
}

Related drugs

Other records sharing ATC code N05AE05.

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