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United States · US · US:33342-276_2abbe156-e5ab-484c-aed7-fa4b5f06698d
Darifenacin
Orange BookUNIISPLATC G04BD10
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMacleods Pharmaceuticals Limited
CountryUS (United States)
ATC codeG04BD10
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11333422760730 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-276-07)
- ndc11333422761090 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-276-10)
- ndc11333422761210 BLISTER PACK in 1 CARTON (33342-276-12) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
CR02EYQ8GV
DARIFENACIN HYDROBROMIDE
RxCUI 485417
Orange Book
A207302
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": "33342-276_2abbe156-e5ab-484c-aed7-fa4b5f06698d",
"productndc": "33342-276",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "207302",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 7.5MG BASE",
"product_no": "001",
"approval_date": "Jul 28, 2017"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "EQ 15MG BASE",
"product_no": "002",
"approval_date": "Jul 28, 2017"
}
],
"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": "ANDA207302",
"marketing_category": "ANDA",
"nonproprietary_name": "Darifenacin",
"start_marketing_date": "20170729",
"active_numerator_strength": "7.5"
}Related drugs
Other records sharing ATC code G04BD10.
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