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United States · US · US:80725-141_f2798247-00df-4ec2-a6f8-1902f10b5558
Coreg
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
- ndc118072514120100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80725-141-20)
Annotations
UNII (FDA Substance ID)
0K47UL67F2
CARVEDILOL
RxCUI 20352
Orange Book
N020297
ABABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "0K47UL67F2",
"rxcui": "20352",
"inchikey": "OGHNVEJMJSYVRP-UHFFFAOYSA-N",
"display_name": "CARVEDILOL",
"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": "80725-141_f2798247-00df-4ec2-a6f8-1902f10b5558",
"productndc": "80725-141",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "020297",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "25MG",
"product_no": "001",
"approval_date": "Sep 14, 1995"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "12.5MG",
"product_no": "002",
"approval_date": "Sep 14, 1995"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "6.25MG",
"product_no": "003",
"approval_date": "Sep 14, 1995"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "3.125MG",
"product_no": "004",
"approval_date": "May 29, 1997"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CARVEDILOL",
"proprietary_name": "Coreg",
"active_ingred_unit": "mg/1",
"application_number": "NDA020297",
"marketing_category": "NDA",
"nonproprietary_name": "Carvedilol",
"start_marketing_date": "20230315",
"active_numerator_strength": "12.5"
}Related drugs
Other records sharing ATC code C07AG02.
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