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United States · US · US:65862-862_389b20f0-64d5-46f6-bb3b-74feb1a9898b
Darifenacin
Orange BookUNIISPLATC G04BD10
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeG04BD10
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc116586286205500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-862-05)
- ndc11658628623030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-862-30)
- ndc11658628629090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-862-90)
- ndc1165862862991000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-862-99)
Annotations
UNII (FDA Substance ID)
CR02EYQ8GV
DARIFENACIN HYDROBROMIDE
RxCUI 485417
Orange Book
A206743
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": "65862-862_389b20f0-64d5-46f6-bb3b-74feb1a9898b",
"productndc": "65862-862",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "206743",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 7.5MG BASE",
"product_no": "001",
"approval_date": "Sep 19, 2016"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 15MG BASE",
"product_no": "002",
"approval_date": "Sep 19, 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": "ANDA206743",
"marketing_category": "ANDA",
"nonproprietary_name": "Darifenacin",
"start_marketing_date": "20160919",
"active_numerator_strength": "15"
}Related drugs
Other records sharing ATC code G04BD10.
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