Solifenacin Succinate

Orange BookUNIISPLATC G04BD08

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

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeG04BD08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
8280404430
30 TABLET, FILM COATED in 1 BOTTLE (82804-044-30)
ndc11
8280404460
60 TABLET, FILM COATED in 1 BOTTLE (82804-044-60)
ndc11
8280404490
90 TABLET, FILM COATED in 1 BOTTLE (82804-044-90)

Annotations

UNII (FDA Substance ID)

KKA5DLD701

SOLIFENACIN SUCCINATE

RxCUI 476588

Orange Book

A211701

ABAB

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": {
    "1d8e8f6f-0a59-479f-8415-c5c5f19e1977": {
      "match": "brand_token",
      "title": "SOLIFENACIN SUCCINATE TABLET, FILM COATED [PROFICIENT RX LP]",
      "spl_version": "1",
      "published_date": "2026-02-10"
    }
  },
  "productid": "82804-044_8ab4f222-018f-40fc-a6aa-39dab563a8a0",
  "productndc": "82804-044",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "211701",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Aug 27, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Aug 27, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SOLIFENACIN SUCCINATE",
  "proprietary_name": "Solifenacin Succinate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA211701",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Solifenacin Succinate",
  "start_marketing_date": "20200323",
  "active_numerator_strength": "5"
}

Related drugs

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