SOLIFENACIN SUCCINATE

Orange BookUNIISPLATC G04BD08

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

Identification

ManufacturerScieGen Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeG04BD08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
5022842705
500 TABLET, FILM COATED in 1 BOTTLE (50228-427-05)
ndc11
5022842730
30 TABLET, FILM COATED in 1 BOTTLE (50228-427-30)
ndc11
5022842790
90 TABLET, FILM COATED in 1 BOTTLE (50228-427-90)

Annotations

UNII (FDA Substance ID)

KKA5DLD701

SOLIFENACIN SUCCINATE

RxCUI 476588

Orange Book

A211657

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": "50228-427_b9432117-2521-7360-e053-2a95a90acd2a",
  "productndc": "50228-427",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "211657",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "May 20, 2019"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "May 20, 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": "ANDA211657",
  "marketing_category": "ANDA",
  "nonproprietary_name": "SOLIFENACIN SUCCINATE",
  "start_marketing_date": "20190520",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code G04BD08.

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