Lurasidone Hydrochloride

Orange BookUNIISPLATC N05AE05

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

Identification

ManufacturerAlembic Pharmaceuticals Limited

CountryUS (United States)

ATC codeN05AE05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
4670849810
100 BLISTER PACK in 1 CARTON (46708-498-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
4670849830
30 TABLET, FILM COATED in 1 BOTTLE (46708-498-30)
ndc11
4670849871
500 TABLET, FILM COATED in 1 BOTTLE (46708-498-71)
ndc11
4670849890
90 TABLET, FILM COATED in 1 BOTTLE (46708-498-90)
ndc11
4670849891
1000 TABLET, FILM COATED in 1 BOTTLE (46708-498-91)

Annotations

UNII (FDA Substance ID)

O0P4I5851I

LURASIDONE HYDROCHLORIDE

RxCUI 1040027

Orange Book

A213248

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": "46708-498_a4f0715d-590f-4b13-bb72-19cdca95aa01",
  "productndc": "46708-498",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "213248",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "May 13, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "002",
        "approval_date": "May 13, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "60MG",
        "product_no": "003",
        "approval_date": "May 13, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "80MG",
        "product_no": "004",
        "approval_date": "May 13, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "120MG",
        "product_no": "005",
        "approval_date": "May 13, 2021"
      }
    ],
    "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": "ANDA213248",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lurasidone Hydrochloride",
  "start_marketing_date": "20230124",
  "active_numerator_strength": "120"
}

Related drugs

Other records sharing ATC code N05AE05.

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