solifenacin succinate

Orange BookUNIISPLATC G04BD08

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

Identification

ManufacturerGlenmark Pharmaceuticals Inc., USA

CountryUS (United States)

ATC codeG04BD08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
6846238714
10 BLISTER PACK in 1 CARTON (68462-387-14) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
ndc11
6846238730
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-387-30)
ndc11
6846238790
90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-387-90)

Annotations

UNII (FDA Substance ID)

KKA5DLD701

SOLIFENACIN SUCCINATE

RxCUI 476588

Orange Book

A209239

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": "68462-387_85807e7f-3f25-4df8-812e-fa6b281d559b",
  "productndc": "68462-387",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "209239",
    "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": "ANDA209239",
  "marketing_category": "ANDA",
  "nonproprietary_name": "solifenacin succinate",
  "start_marketing_date": "20190520",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code G04BD08.

Access this data programmatically

Query solifenacin succinate and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs