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United States · US · US:64380-781_955b2f6c-9576-488f-bbcb-2c442fa40c72

Oxybutynin Chloride

Orange BookUNIISPLATC G04BD04

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

Identification

ManufacturerStrides Pharma Science Limited
CountryUS (United States)
ATC codeG04BD04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    6438078103
    60 TABLET in 1 BOTTLE (64380-781-03)
  • ndc11
    6438078105
    90 TABLET in 1 BOTTLE (64380-781-05)
  • ndc11
    6438078106
    100 TABLET in 1 BOTTLE (64380-781-06)
  • ndc11
    6438078107
    500 TABLET in 1 BOTTLE (64380-781-07)
  • ndc11
    6438078108
    1000 TABLET in 1 BOTTLE (64380-781-08)

Annotations

UNII (FDA Substance ID)
L9F3D9RENQ
OXYBUTYNIN CHLORIDE
RxCUI 54251
Orange Book
A208165
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": "64380-781_955b2f6c-9576-488f-bbcb-2c442fa40c72",
  "productndc": "64380-781",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "208165",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Dec 17, 2020"
      }
    ],
    "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": "ANDA208165",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Oxybutynin Chloride",
  "start_marketing_date": "20241220",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code G04BD04.

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