Solifenacin Succinate

Orange BookUNIISPLATC G04BD08

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

Identification

ManufacturerAlembic Pharmaceuticals Inc.

CountryUS (United States)

ATC codeG04BD08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
6233219308
80 TABLET, COATED in 1 CARTON (62332-193-08)
ndc11
6233219330
30 TABLET, COATED in 1 BOTTLE (62332-193-30)
ndc11
6233219390
90 TABLET, COATED in 1 BOTTLE (62332-193-90)
ndc11
6233219391
1000 TABLET, COATED in 1 BOTTLE (62332-193-91)

Annotations

UNII (FDA Substance ID)

KKA5DLD701

SOLIFENACIN SUCCINATE

RxCUI 476588

Orange Book

A205575

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": "62332-193_b7806d00-75b4-482e-8e83-d71a9ca8e012",
  "productndc": "62332-193",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "205575",
    "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": "ANDA205575",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Solifenacin Succinate",
  "start_marketing_date": "20190520",
  "active_numerator_strength": "10"
}

Related drugs

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