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United States · US · US:31722-027_e52cdf06-9178-ab2f-e053-2a95a90af2b3

solifenacin succinate

Orange BookUNIISPLATC G04BD08

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerCamber Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeG04BD08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    3172202730
    30 TABLET, FILM COATED in 1 BOTTLE (31722-027-30)
  • ndc11
    3172202731
    10 BLISTER PACK in 1 CARTON (31722-027-31) / 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-027-32)
  • ndc11
    3172202790
    90 TABLET, FILM COATED in 1 BOTTLE (31722-027-90)

Annotations

UNII (FDA Substance ID)
KKA5DLD701
SOLIFENACIN SUCCINATE
RxCUI 476588
Orange Book
A215761
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": "31722-027_e52cdf06-9178-ab2f-e053-2a95a90af2b3",
  "productndc": "31722-027",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "215761",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Jun 15, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Jun 15, 2022"
      }
    ],
    "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": "ANDA215761",
  "marketing_category": "ANDA",
  "nonproprietary_name": "solifenacin succinate",
  "start_marketing_date": "20220615",
  "active_numerator_strength": "5"
}

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