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United States · US · US:0574-0115_ff1c0ee9-75d2-478a-9152-0753be81ff11

FLAVOXATE HYDROCHLORIDE

Orange BookUNIISPLATC G04BD02

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

Identification

ManufacturerPadagis US LLC
CountryUS (United States)
ATC codeG04BD02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0574011501
    100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0574-0115-01)

Annotations

UNII (FDA Substance ID)
9C05J6089W
FLAVOXATE HYDROCHLORIDE
RxCUI 142437
Orange Book
A076831
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "9C05J6089W",
    "rxcui": "142437",
    "inchikey": "XOEVKNFZUQEERE-UHFFFAOYSA-N",
    "display_name": "FLAVOXATE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "f6a06eda-2480-4c0d-8d1e-9e3e89d3ee88": {
      "match": "brand_token",
      "title": "FLAVOXATE HYDROCHLORIDE TABLET [PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS]",
      "spl_version": "6",
      "published_date": "2025-12-12"
    }
  },
  "productid": "0574-0115_ff1c0ee9-75d2-478a-9152-0753be81ff11",
  "productndc": "0574-0115",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "076831",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Dec 16, 2004"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLAVOXATE HYDROCHLORIDE",
  "proprietary_name": "FLAVOXATE HYDROCHLORIDE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA076831",
  "marketing_category": "ANDA",
  "nonproprietary_name": "FLAVOXATE HYDROCHLORIDE",
  "start_marketing_date": "20041222",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code G04BD02.

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