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United States · US · US:65862-145_f210723f-29fb-46c7-8ac4-5009d9696d3b
Carvedilol
Orange BookUNIISPLATC C07AG02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeC07AG02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc116586214501100 TABLET, FILM COATED in 1 BOTTLE (65862-145-01)
- ndc116586214505500 TABLET, FILM COATED in 1 BOTTLE (65862-145-05)
- ndc1165862145991000 TABLET, FILM COATED in 1 BOTTLE (65862-145-99)
Annotations
UNII (FDA Substance ID)
0K47UL67F2
CARVEDILOL
RxCUI 20352
Orange Book
A078332
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": {
"52bd1d20-08ba-1e5e-e063-6294a90ae8a9": {
"match": "brand_token",
"title": "CARVEDILOL TABLET, FILM COATED [COUPLER LLC]",
"spl_version": "1",
"published_date": "2026-05-28"
}
},
"productid": "65862-145_f210723f-29fb-46c7-8ac4-5009d9696d3b",
"productndc": "65862-145",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "078332",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "3.125MG",
"product_no": "001",
"approval_date": "Sep 5, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "6.25MG",
"product_no": "002",
"approval_date": "Sep 5, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "12.5MG",
"product_no": "003",
"approval_date": "Sep 5, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "004",
"approval_date": "Sep 5, 2007"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CARVEDILOL",
"proprietary_name": "Carvedilol",
"active_ingred_unit": "mg/1",
"application_number": "ANDA078332",
"marketing_category": "ANDA",
"nonproprietary_name": "Carvedilol",
"start_marketing_date": "20070905",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code C07AG02.
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