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United States · US · US:70954-005_db0e9137-4243-4f35-87fb-19668c1bd480
Oxybutynin Chloride
Orange BookUNIISPLATC G04BD04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerANI Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeG04BD04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc117095400510100 TABLET in 1 BOTTLE (70954-005-10)
- ndc117095400520500 TABLET in 1 BOTTLE (70954-005-20)
- ndc1170954005301000 TABLET in 1 BOTTLE (70954-005-30)
- ndc117095400550100 BLISTER PACK in 1 CARTON (70954-005-50) / 1 TABLET in 1 BLISTER PACK (70954-005-40)
Annotations
UNII (FDA Substance ID)
L9F3D9RENQ
OXYBUTYNIN CHLORIDE
RxCUI 54251
Orange Book
A209823
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": "70954-005_db0e9137-4243-4f35-87fb-19668c1bd480",
"productndc": "70954-005",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "209823",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "Oct 23, 2017"
}
],
"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": "ANDA209823",
"marketing_category": "ANDA",
"nonproprietary_name": "Oxybutynin Chloride",
"start_marketing_date": "20171115",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code G04BD04.
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