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United States · US · US:65162-371_25b959bc-5b59-4c9c-b7a0-ae475a8e0290
Oxybutynin Chloride
Orange BookUNIISPLATC G04BD04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeG04BD04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11651623710330 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-371-03)
- ndc11651623710990 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-371-09)
- ndc116516237110100 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-371-10)
- ndc116516237150500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-371-50)
Annotations
UNII (FDA Substance ID)
L9F3D9RENQ
OXYBUTYNIN CHLORIDE
RxCUI 54251
Orange Book
A204010
ABABAB
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": "65162-371_25b959bc-5b59-4c9c-b7a0-ae475a8e0290",
"productndc": "65162-371",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "204010",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "Nov 23, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Nov 23, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "15MG",
"product_no": "003",
"approval_date": "Nov 23, 2015"
}
],
"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": "ANDA204010",
"marketing_category": "ANDA",
"nonproprietary_name": "Oxybutynin Chloride",
"start_marketing_date": "20151102",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code G04BD04.
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