OXYBUTYNIN CHLORIDE

Orange BookUNIISPLATC G04BD04

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeG04BD04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 8

ndc11
7133510141
30 TABLET in 1 BOTTLE (71335-1014-1)
ndc11
7133510142
100 TABLET in 1 BOTTLE (71335-1014-2)
ndc11
7133510143
20 TABLET in 1 BOTTLE (71335-1014-3)
ndc11
7133510144
60 TABLET in 1 BOTTLE (71335-1014-4)
ndc11
7133510145
90 TABLET in 1 BOTTLE (71335-1014-5)
ndc11
7133510146
42 TABLET in 1 BOTTLE (71335-1014-6)
ndc11
7133510147
15 TABLET in 1 BOTTLE (71335-1014-7)
ndc11
7133510148
180 TABLET in 1 BOTTLE (71335-1014-8)

Annotations

UNII (FDA Substance ID)

L9F3D9RENQ

OXYBUTYNIN CHLORIDE

RxCUI 54251

Orange Book

A209025

ABAB

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": "71335-1014_d8012174-1a1c-46d9-9e97-094e9462a1f4",
  "productndc": "71335-1014",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "209025",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Dec 21, 2017"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "002",
        "approval_date": "Feb 7, 2023"
      }
    ],
    "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": "ANDA209025",
  "marketing_category": "ANDA",
  "nonproprietary_name": "OXYBUTYNIN CHLORIDE",
  "start_marketing_date": "20180201",
  "active_numerator_strength": "5"
}

Related drugs

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