Solifenacin Succinate

Orange BookUNIISPLATC G04BD08

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

Identification

ManufacturerQilu Pharmaceutical Co., Ltd.

CountryUS (United States)

ATC codeG04BD08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
6718405171
30 TABLET, FILM COATED in 1 BOTTLE (67184-0517-1)
ndc11
6718405172
90 TABLET, FILM COATED in 1 BOTTLE (67184-0517-2)
ndc11
6718405173
2000 TABLET, FILM COATED in 1 BOTTLE (67184-0517-3)
ndc11
6718405174
40 TABLET, FILM COATED in 1 BLISTER PACK (67184-0517-4)

Annotations

UNII (FDA Substance ID)

KKA5DLD701

SOLIFENACIN SUCCINATE

RxCUI 476588

Orange Book

A209333

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": "67184-0517_4ad0176d-0102-457a-9fcb-472dcedd9709",
  "productndc": "67184-0517",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "209333",
    "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": "ANDA209333",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Solifenacin Succinate Tablets",
  "start_marketing_date": "20200401",
  "active_numerator_strength": "10"
}

Related drugs

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