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United States · US · US:46708-223_70d8a245-0125-4c31-b941-2137d96c43c3
DARIFENACIN
Orange BookUNIISPLATC G04BD10
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlembic Pharmaceuticals Limited
CountryUS (United States)
ATC codeG04BD10
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc1146708223088 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (46708-223-08)
- ndc11467082233030 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-223-30)
- ndc11467082239090 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-223-90)
- ndc1146708223911000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-223-91)
Annotations
UNII (FDA Substance ID)
CR02EYQ8GV
DARIFENACIN HYDROBROMIDE
RxCUI 485417
Orange Book
A207681
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": "46708-223_70d8a245-0125-4c31-b941-2137d96c43c3",
"productndc": "46708-223",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "207681",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 7.5MG BASE",
"product_no": "001",
"approval_date": "Dec 8, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 15MG BASE",
"product_no": "002",
"approval_date": "Dec 8, 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": "ANDA207681",
"marketing_category": "ANDA",
"nonproprietary_name": "DARIFENACIN",
"start_marketing_date": "20171212",
"active_numerator_strength": "7.5"
}Related drugs
Other records sharing ATC code G04BD10.
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