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United States · US · US:51248-150_5de8c6b0-8a05-4b69-ae10-ffc7ddd286e3

VESIcare

Orange BookUNIISPLATC G04BD08

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAstellas Pharma US, Inc.
CountryUS (United States)
ATC codeG04BD08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5124815001
    30 TABLET, FILM COATED in 1 BOTTLE (51248-150-01)

Annotations

UNII (FDA Substance ID)
KKA5DLD701
SOLIFENACIN SUCCINATE
RxCUI 476588
Orange Book
N021518
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "KKA5DLD701",
    "rxcui": "476588",
    "inchikey": "RXZMMZZRUPYENV-VROPFNGYSA-N",
    "display_name": "SOLIFENACIN SUCCINATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "e0300384-e980-45d5-8ed4-48a2618671ae": {
      "match": "brand_token",
      "title": "VESICARE LS (SOLIFENACIN SUCCINATE) SUSPENSION [ASTELLAS PHARMA US, INC.]",
      "spl_version": "4",
      "published_date": "2026-03-25"
    }
  },
  "productid": "51248-150_5de8c6b0-8a05-4b69-ae10-ffc7ddd286e3",
  "productndc": "51248-150",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "021518",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Nov 19, 2004"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Nov 19, 2004"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SOLIFENACIN SUCCINATE",
  "proprietary_name": "VESIcare",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021518",
  "marketing_category": "NDA",
  "nonproprietary_name": "solifenacin succinate",
  "start_marketing_date": "20050105",
  "active_numerator_strength": "5"
}

Related drugs

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