Jynarque

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
5914808728
4 BLISTER PACK in 1 CARTON (59148-087-28) / 1 KIT in 1 BLISTER PACK (59148-087-07)

Annotations

Orange Book

N204441

AB2AB2ABAB2AB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "3febc0a1-9e5a-4ce0-843d-210f21d862c4": {
      "match": "brand_token",
      "title": "JYNARQUE (TOLVAPTAN) KIT JYNARQUE (TOLVAPTAN) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.]",
      "spl_version": "19",
      "published_date": "2025-11-17"
    }
  },
  "productid": "59148-087_3be8a6fe-a8d0-43ca-a84d-183b522a3cf4",
  "productndc": "59148-087",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "204441",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB2",
        "strength": "15MG",
        "product_no": "001",
        "approval_date": "Apr 23, 2018"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB2",
        "strength": "30MG",
        "product_no": "002",
        "approval_date": "Apr 23, 2018"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "45MG",
        "product_no": "003",
        "approval_date": "Apr 23, 2018"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB2",
        "strength": "60MG",
        "product_no": "004",
        "approval_date": "Apr 23, 2018"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "90MG",
        "product_no": "005",
        "approval_date": "Apr 23, 2018"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Jynarque",
  "active_ingred_unit": null,
  "application_number": "NDA204441",
  "marketing_category": "NDA",
  "nonproprietary_name": "tolvaptan",
  "start_marketing_date": "20180423",
  "active_numerator_strength": null
}

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