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United States · US · US:70771-1086_e2d9aa83-078e-4c67-a9d0-8c166bc4d9f0
oxybutynin
Orange BookUNIISPLATC G04BD04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeG04BD04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc117077110861100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1086-1)
- ndc11707711086330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1086-3)
- ndc11707711086410 BLISTER PACK in 1 CARTON (70771-1086-4) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (70771-1086-2)
- ndc117077110865500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1086-5)
- ndc11707711086660 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1086-6)
- ndc11707711086990 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1086-9)
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": "70771-1086_e2d9aa83-078e-4c67-a9d0-8c166bc4d9f0",
"productndc": "70771-1086",
"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": "5"
}Related drugs
Other records sharing ATC code G04BD04.
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