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United States · US · US:71610-277_b28dba2b-b19b-469e-98d8-54e87e3800e3
Oxybutynin Chloride
Orange BookUNIISPLATC G04BD04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAphena Pharma Solutions - Tennessee, LLC
CountryUS (United States)
ATC codeG04BD04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc11716102773030 TABLET in 1 BOTTLE (71610-277-30)
- ndc11716102775360 TABLET in 1 BOTTLE (71610-277-53)
- ndc11716102776090 TABLET in 1 BOTTLE (71610-277-60)
- ndc117161027780180 TABLET in 1 BOTTLE (71610-277-80)
- ndc117161027792270 TABLET in 1 BOTTLE (71610-277-92)
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": "71610-277_b28dba2b-b19b-469e-98d8-54e87e3800e3",
"productndc": "71610-277",
"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": "20171023",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code G04BD04.
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