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United States · US · US:0023-6153_12aace89-ecb2-4706-a0bd-5bd24b8db2ed

OXYTROL

Orange BookUNIISPLATC G04BD04

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

Identification

ManufacturerAllergan, Inc.
CountryUS (United States)
ATC codeG04BD04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 0

No packs registered.

Annotations

UNII (FDA Substance ID)
K9P6MC7092
OXYBUTYNIN
RxCUI 32675
Orange Book
N021351
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "K9P6MC7092",
    "rxcui": "32675",
    "inchikey": "XIQVNETUBQGFHX-UHFFFAOYSA-N",
    "display_name": "OXYBUTYNIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TRANSDERMAL",
  "spl_meta": {
    "8cdc5b4d-ff8d-4010-97d7-313422a0b868": {
      "match": "brand_token",
      "title": "OXYTROL FOR WOMEN (OXYBUTYNIN) PATCH [ALLERGAN, INC.]",
      "spl_version": "7",
      "published_date": "2025-01-09"
    }
  },
  "productid": "0023-6153_12aace89-ecb2-4706-a0bd-5bd24b8db2ed",
  "productndc": "0023-6153",
  "dosage_form": "PATCH",
  "orange_book": {
    "appl_no": "021351",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "3.9MG/24HR",
        "product_no": "002",
        "approval_date": "Feb 26, 2003"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OXYBUTYNIN",
  "proprietary_name": "OXYTROL",
  "active_ingred_unit": "mg/d",
  "application_number": "NDA021351",
  "marketing_category": "NDA",
  "nonproprietary_name": "Oxybutynin",
  "start_marketing_date": "20030226",
  "active_numerator_strength": "3.9"
}

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