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United States · US · US:80725-383_d756f678-86ff-4187-9cc1-68dd3a383af8
Coreg CR
Orange BookUNIISPLATC C07AG02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerWaylis Therapeutics LLC
CountryUS (United States)
ATC codeC07AG02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11807253831330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (80725-383-13)
Annotations
UNII (FDA Substance ID)
EQT531S367
CARVEDILOL PHOSPHATE
RxCUI 668310
Orange Book
N022012
ABABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "EQT531S367",
"rxcui": "668310",
"inchikey": "LHNYXTULDSJZRB-UHFFFAOYSA-N",
"display_name": "CARVEDILOL PHOSPHATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"d3625d78-6eb6-41fe-8f6f-664965c104c4": {
"match": "brand_token",
"title": "COREG CR (CARVEDILOL PHOSPHATE) CAPSULE, EXTENDED RELEASE [WAYLIS THERAPEUTICS LLC]",
"spl_version": "3",
"published_date": "2025-04-28"
}
},
"productid": "80725-383_d756f678-86ff-4187-9cc1-68dd3a383af8",
"productndc": "80725-383",
"dosage_form": "CAPSULE, EXTENDED RELEASE",
"orange_book": {
"appl_no": "022012",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Oct 20, 2006"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "20MG",
"product_no": "002",
"approval_date": "Oct 20, 2006"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "40MG",
"product_no": "003",
"approval_date": "Oct 20, 2006"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "80MG",
"product_no": "004",
"approval_date": "Oct 20, 2006"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CARVEDILOL PHOSPHATE",
"proprietary_name": "Coreg CR",
"active_ingred_unit": "mg/1",
"application_number": "NDA022012",
"marketing_category": "NDA",
"nonproprietary_name": "Carvedilol Phosphate",
"start_marketing_date": "20221107",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code C07AG02.
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