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United States · US · US:64980-531_92fdb885-c818-4c39-909a-7f2f53840d90
OXYBUTYNIN CHLORIDE
Orange BookUNIISPLATC G04BD04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRISING PHARMA HOLDINGS, INC.
CountryUS (United States)
ATC codeG04BD04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116498053101100 TABLET in 1 BOTTLE (64980-531-01)
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": "64980-531_92fdb885-c818-4c39-909a-7f2f53840d90",
"productndc": "64980-531",
"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": "20230401",
"active_numerator_strength": "2.5"
}Related drugs
Other records sharing ATC code G04BD04.
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