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United States · US · US:69097-432_99ca2704-b757-4f10-be5c-bd01dff69b10
Darifenacin
Orange BookUNIISPLATC G04BD10
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCipla USA Inc.
CountryUS (United States)
ATC codeG04BD10
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11690974320230 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-432-02)
- ndc11690974320590 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-432-05)
- ndc1169097432151000 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-432-15)
Annotations
UNII (FDA Substance ID)
CR02EYQ8GV
DARIFENACIN HYDROBROMIDE
RxCUI 485417
Orange Book
A207664
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": "69097-432_99ca2704-b757-4f10-be5c-bd01dff69b10",
"productndc": "69097-432",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "207664",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 7.5MG BASE",
"product_no": "001",
"approval_date": "Sep 1, 2016"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 15MG BASE",
"product_no": "002",
"approval_date": "Sep 1, 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": "ANDA207664",
"marketing_category": "ANDA",
"nonproprietary_name": "Darifenacin Hydrobromide",
"start_marketing_date": "20160901",
"active_numerator_strength": "15"
}Related drugs
Other records sharing ATC code G04BD10.
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