Rexulti

Orange BookUNIISPLATC N05AX16

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

Identification

ManufacturerOtsuka America Pharmaceutical, Inc.

CountryUS (United States)

ATC codeN05AX16

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5914803707
1 BLISTER PACK in 1 CARTON (59148-037-07) / 7 TABLET in 1 BLISTER PACK
ndc11
5914803713
1 BOTTLE in 1 CARTON (59148-037-13) / 30 TABLET in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

2J3YBM1K8C

BREXPIPRAZOLE

RxCUI 1658314

Orange Book

N205422

ABABABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "2J3YBM1K8C",
    "rxcui": "1658314",
    "inchikey": "ZKIAIYBUSXZPLP-UHFFFAOYSA-N",
    "display_name": "BREXPIPRAZOLE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "2d301358-6291-4ec1-bd87-37b4ad9bd850": {
      "match": "brand_token",
      "title": "REXULTI (BREXPIPRAZOLE) TABLET REXULTI (BREXPIPRAZOLE) KIT [OTSUKA AMERICA PHARMACEUTICAL, INC.]",
      "spl_version": "26",
      "published_date": "2026-05-28"
    }
  },
  "productid": "59148-037_3a208135-0d99-4d6a-b73e-61d63cf48f4f",
  "productndc": "59148-037",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "205422",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "0.25MG",
        "product_no": "001",
        "approval_date": "Jul 10, 2015"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "0.5MG",
        "product_no": "002",
        "approval_date": "Jul 10, 2015"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "003",
        "approval_date": "Jul 10, 2015"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "004",
        "approval_date": "Jul 10, 2015"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "3MG",
        "product_no": "005",
        "approval_date": "Jul 10, 2015"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "006",
        "approval_date": "Jul 10, 2015"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BREXPIPRAZOLE",
  "proprietary_name": "Rexulti",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA205422",
  "marketing_category": "NDA",
  "nonproprietary_name": "brexpiprazole",
  "start_marketing_date": "20150710",
  "active_numerator_strength": "1"
}

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