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United States · US · US:51248-250_de0d92da-e334-4032-bbac-d3c8177d4bf4

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
    5124825099
    1 BOTTLE, PLASTIC in 1 CARTON (51248-250-99) / 150 mL in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)
KKA5DLD701
SOLIFENACIN SUCCINATE
RxCUI 476588
Orange Book
N209529
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": "51248-250_de0d92da-e334-4032-bbac-d3c8177d4bf4",
  "productndc": "51248-250",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "209529",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "1MG/ML",
        "product_no": "001",
        "approval_date": "May 26, 2020"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SOLIFENACIN SUCCINATE",
  "proprietary_name": "VESIcare",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA209529",
  "marketing_category": "NDA",
  "nonproprietary_name": "solifenacin succinate",
  "start_marketing_date": "20200526",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code G04BD08.

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