Lurasidone hydrochloride

Orange BookUNIISPLATC N05AE05

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

Identification

ManufacturerDr. Reddys Laboratories Inc

CountryUS (United States)

ATC codeN05AE05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
4359835105
500 TABLET, FILM COATED in 1 BOTTLE (43598-351-05)
ndc11
4359835130
30 TABLET, FILM COATED in 1 BOTTLE (43598-351-30)
ndc11
4359835178
10 BLISTER PACK in 1 CARTON (43598-351-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (43598-351-79)
ndc11
4359835190
90 TABLET, FILM COATED in 1 BOTTLE (43598-351-90)

Annotations

UNII (FDA Substance ID)

O0P4I5851I

LURASIDONE HYDROCHLORIDE

RxCUI 1040027

Orange Book

A208047

ABABABAB

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": "43598-351_f3c17d88-383d-89de-d8d6-8ed1bb1b3750",
  "productndc": "43598-351",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "208047",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Aug 24, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "002",
        "approval_date": "Aug 24, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "60MG",
        "product_no": "003",
        "approval_date": "Aug 24, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "80MG",
        "product_no": "004",
        "approval_date": "Aug 24, 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": "ANDA208047",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lurasidone hydrochloride",
  "start_marketing_date": "20230220",
  "active_numerator_strength": "20"
}

Related drugs

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