solifenacin succinate

Orange BookUNIISPLATC G04BD08

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

Identification

ManufacturerMacleods Pharmaceuticals Limited

CountryUS (United States)

ATC codeG04BD08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
3334214907
30 TABLET, COATED in 1 CONTAINER (33342-149-07)
ndc11
3334214910
90 TABLET, COATED in 1 CONTAINER (33342-149-10)

Annotations

UNII (FDA Substance ID)

KKA5DLD701

SOLIFENACIN SUCCINATE

RxCUI 476588

Orange Book

A204374

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": "33342-149_fbd6e753-1ed2-418a-8667-c674b215eabb",
  "productndc": "33342-149",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "204374",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Feb 20, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Feb 20, 2024"
      }
    ],
    "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": "ANDA204374",
  "marketing_category": "ANDA",
  "nonproprietary_name": "solifenacin succinate",
  "start_marketing_date": "20240220",
  "active_numerator_strength": "10"
}

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