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United States · US · US:13668-203_fe809224-0deb-4a82-b454-054be6dd4931
Darifenacin
Orange BookUNIISPLATC G04BD10
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTorrent Pharmaceuticals Limited
CountryUS (United States)
ATC codeG04BD10
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc111366820305500 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-203-05)
- ndc11136682033030 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-203-30)
- ndc11136682039090 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-203-90)
Annotations
UNII (FDA Substance ID)
CR02EYQ8GV
DARIFENACIN HYDROBROMIDE
RxCUI 485417
Orange Book
A205209
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "CR02EYQ8GV",
"rxcui": "485417",
"inchikey": "UQAVIASOPREUIT-VQIWEWKSSA-N",
"display_name": "DARIFENACIN HYDROBROMIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"e84f1ae3-b9a2-4a15-a299-c75373891cc1": {
"match": "brand_token",
"title": "DARIFENACIN TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]",
"spl_version": "10",
"published_date": "2026-03-03"
}
},
"productid": "13668-203_fe809224-0deb-4a82-b454-054be6dd4931",
"productndc": "13668-203",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "205209",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 7.5MG BASE",
"product_no": "001",
"approval_date": "Nov 17, 2016"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 15MG BASE",
"product_no": "002",
"approval_date": "Nov 17, 2016"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DARIFENACIN HYDROBROMIDE",
"proprietary_name": "Darifenacin",
"active_ingred_unit": "mg/1",
"application_number": "ANDA205209",
"marketing_category": "ANDA",
"nonproprietary_name": "Darifenacin",
"start_marketing_date": "20161118",
"active_numerator_strength": "15"
}Related drugs
Other records sharing ATC code G04BD10.
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