Solifenacin Succinate

Orange BookUNIISPLATC G04BD08

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

Identification

ManufacturerBostal LLC

CountryUS (United States)

ATC codeG04BD08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
3556128500
256410 TABLET, FILM COATED in 1 BOX (35561-285-00)
ndc11
3556128510
30 TABLET, FILM COATED in 1 BOTTLE (35561-285-10)
ndc11
3556128511
90 TABLET, FILM COATED in 1 BOTTLE (35561-285-11)
ndc11
3556128513
500 TABLET, FILM COATED in 1 BOTTLE (35561-285-13)

Annotations

UNII (FDA Substance ID)

KKA5DLD701

SOLIFENACIN SUCCINATE

RxCUI 476588

Orange Book

A210281

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": "35561-285_49fcc8a4-31aa-6975-e063-6394a90a9389",
  "productndc": "35561-285",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "210281",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "May 20, 2019"
      },
      {
        "rs": false,
        "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": "ANDA210281",
  "marketing_category": "ANDA",
  "nonproprietary_name": "solifenacin succiate",
  "start_marketing_date": "20190520",
  "active_numerator_strength": "5"
}

Related drugs

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