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United States · US · US:68999-520_499c11a1-a248-9411-e063-6294a90a203a

Oxybutynin Chloride

Orange BookUNIISPLATC G04BD04

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

Identification

ManufacturerChartwell Governmental & Specialty RX, LLC.
CountryUS (United States)
ATC codeG04BD04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6899952024
    2 TRAY in 1 BOX (68999-520-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-520-05)

Annotations

UNII (FDA Substance ID)
L9F3D9RENQ
OXYBUTYNIN CHLORIDE
RxCUI 54251
Orange Book
A075039
AA
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "L9F3D9RENQ",
    "rxcui": "54251",
    "inchikey": "SWIJYDAEGSIQPZ-UHFFFAOYSA-N",
    "display_name": "OXYBUTYNIN CHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "73d715dc-868d-4194-b668-4c39ababa698": {
      "match": "brand_token",
      "title": "OXYBUTYNIN CHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]",
      "spl_version": "2",
      "published_date": "2026-06-02"
    }
  },
  "productid": "68999-520_499c11a1-a248-9411-e063-6294a90a203a",
  "productndc": "68999-520",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "075039",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "5MG/5ML",
        "product_no": "001",
        "approval_date": "Jan 29, 1999"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OXYBUTYNIN CHLORIDE",
  "proprietary_name": "Oxybutynin Chloride",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA075039",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Oxybutynin Chloride",
  "start_marketing_date": "19990129",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code G04BD04.

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