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United States · US · US:68382-257_f54e4d4e-91be-4e10-a446-57ed5e1843a1
oxybutynin
Orange BookUNIISPLATC G04BD04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeG04BD04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc116838225701100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-257-01)
- ndc116838225705500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-257-05)
- ndc11683822570630 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-257-06)
- ndc11683822571460 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-257-14)
- ndc11683822571690 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-257-16)
- ndc11683822577710 BLISTER PACK in 1 CARTON (68382-257-77) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68382-257-30)
Annotations
UNII (FDA Substance ID)
L9F3D9RENQ
OXYBUTYNIN CHLORIDE
RxCUI 54251
Orange Book
A202332
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": "68382-257_f54e4d4e-91be-4e10-a446-57ed5e1843a1",
"productndc": "68382-257",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "202332",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "Jun 26, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Jun 26, 2017"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "15MG",
"product_no": "003",
"approval_date": "Jun 26, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "OXYBUTYNIN CHLORIDE",
"proprietary_name": "oxybutynin",
"active_ingred_unit": "mg/1",
"application_number": "ANDA202332",
"marketing_category": "ANDA",
"nonproprietary_name": "oxybutynin",
"start_marketing_date": "20170810",
"active_numerator_strength": "15"
}Related drugs
Other records sharing ATC code G04BD04.
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