Rexulti

Orange BookSPL

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

Identification

ManufacturerOtsuka America Pharmaceutical, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5914804207
1 KIT in 1 CARTON (59148-042-07) * 4 TABLET in 1 BLISTER PACK * 3 TABLET in 1 BLISTER PACK

Annotations

Orange Book

N205422

ABABABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "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": "59148-042_3a208135-0d99-4d6a-b73e-61d63cf48f4f",
  "productndc": "59148-042",
  "dosage_form": "KIT",
  "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": null,
  "proprietary_name": "Rexulti",
  "active_ingred_unit": null,
  "application_number": "NDA205422",
  "marketing_category": "NDA",
  "nonproprietary_name": "BREXPIPRAZOLE",
  "start_marketing_date": "20150710",
  "active_numerator_strength": null
}

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