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United States · US · US:83939-0022_427b8d8e-0187-6ba0-e063-6294a90ac52b

Oxybutynin Chloride

Orange BookUNIISPLATC G04BD04

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

Identification

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

Packs · 3

  • ndc11
    8393900221
    1 TABLET in 1 POUCH (83939-0022-1)
  • ndc11
    8393900222
    50 POUCH in 1 BOX, UNIT-DOSE (83939-0022-2) / 1 TABLET in 1 POUCH
  • ndc11
    8393900223
    100 POUCH in 1 BOX, UNIT-DOSE (83939-0022-3) / 1 TABLET in 1 POUCH

Annotations

UNII (FDA Substance ID)
L9F3D9RENQ
OXYBUTYNIN CHLORIDE
RxCUI 54251
Orange Book
A209823
AB
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": "83939-0022_427b8d8e-0187-6ba0-e063-6294a90ac52b",
  "productndc": "83939-0022",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "209823",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Oct 23, 2017"
      }
    ],
    "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": "ANDA209823",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Oxybutynin Chloride",
  "start_marketing_date": "20171115",
  "active_numerator_strength": "5"
}

Related drugs

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