Oxybutynin Chloride

Orange BookUNIISPLATC G04BD04

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

Identification

ManufacturerAvKARE

CountryUS (United States)

ATC codeG04BD04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
4229163401
100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-634-01)
ndc11
4229163450
500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-634-50)

Annotations

UNII (FDA Substance ID)

L9F3D9RENQ

OXYBUTYNIN CHLORIDE

RxCUI 54251

Orange Book

A078503

ABABAB

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": "42291-634_46143c62-4276-2b49-e063-6294a90ae1aa",
  "productndc": "42291-634",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "078503",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Feb 4, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Feb 4, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "003",
        "approval_date": "Feb 4, 2009"
      }
    ],
    "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": "ANDA078503",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Oxybutynin Chloride",
  "start_marketing_date": "20160309",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code G04BD04.

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