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United States · US · US:23155-913_7adfd07f-bfc6-4403-8f1e-fdc6650dbc50

Oxybutynin Chloride

Orange BookUNIISPLATC G04BD04

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

Identification

ManufacturerHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
CountryUS (United States)
ATC codeG04BD04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    2315591301
    100 TABLET in 1 BOTTLE, PLASTIC (23155-913-01)
  • ndc11
    2315591305
    500 TABLET in 1 BOTTLE, PLASTIC (23155-913-05)
  • ndc11
    2315591310
    1000 TABLET in 1 BOTTLE, PLASTIC (23155-913-10)

Annotations

UNII (FDA Substance ID)
L9F3D9RENQ
OXYBUTYNIN CHLORIDE
RxCUI 54251
Orange Book
A211682
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": "23155-913_7adfd07f-bfc6-4403-8f1e-fdc6650dbc50",
  "productndc": "23155-913",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "211682",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "May 10, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OXYBUTYNIN CHLORIDE",
  "proprietary_name": "Oxybutynin Chloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA211682",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Oxybutynin Chloride",
  "start_marketing_date": "20260601",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code G04BD04.

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