Latuda

Orange BookUNIISPLATC N05AE05

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

Identification

ManufacturerSumitomo Pharma America, Inc.

CountryUS (United States)

ATC codeN05AE05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
6340230204
4 BLISTER PACK in 1 CARTON (63402-302-04) / 7 TABLET, FILM COATED in 1 BLISTER PACK (63402-302-07)
ndc11
6340230210
10 BLISTER PACK in 1 CARTON (63402-302-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK (63402-302-01)
ndc11
6340230230
30 TABLET, FILM COATED in 1 BOTTLE (63402-302-30)
ndc11
6340230250
500 TABLET, FILM COATED in 1 BOTTLE (63402-302-50)
ndc11
6340230290
90 TABLET, FILM COATED in 1 BOTTLE (63402-302-90)

Annotations

UNII (FDA Substance ID)

O0P4I5851I

LURASIDONE HYDROCHLORIDE

RxCUI 1040027

Orange Book

N200603

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": {
    "afad3051-9df2-4c54-9684-e8262a133af8": {
      "match": "brand_token",
      "title": "LATUDA (LURASIDONE HYDROCHLORIDE) TABLET, FILM COATED [SUMITOMO PHARMA AMERICA, INC.]",
      "spl_version": "37",
      "published_date": "2026-01-14"
    }
  },
  "productid": "63402-302_7383b0e0-01e8-4778-96f0-6f2e0c9586ae",
  "productndc": "63402-302",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "200603",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "001",
        "approval_date": "Oct 28, 2010"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "80MG",
        "product_no": "002",
        "approval_date": "Oct 28, 2010"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "003",
        "approval_date": "Dec 7, 2011"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "120MG",
        "product_no": "004",
        "approval_date": "Apr 26, 2012"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "60MG",
        "product_no": "005",
        "approval_date": "Jul 12, 2013"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LURASIDONE HYDROCHLORIDE",
  "proprietary_name": "Latuda",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA200603",
  "marketing_category": "NDA",
  "nonproprietary_name": "lurasidone hydrochloride",
  "start_marketing_date": "20111207",
  "active_numerator_strength": "20"
}

Related drugs

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