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United States · US · US:51655-397_49dc05cf-35ca-a384-e063-6294a90a07e1
Carvedilol
Orange BookUNIISPLATC C07AG02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNorthwind Health Company, LLC
CountryUS (United States)
ATC codeC07AG02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11516553972560 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-397-25)
- ndc11516553972690 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-397-26)
- ndc11516553975230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-397-52)
- ndc115165539783180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-397-83)
Annotations
UNII (FDA Substance ID)
0K47UL67F2
CARVEDILOL
RxCUI 20352
Orange Book
A077614
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": "51655-397_49dc05cf-35ca-a384-e063-6294a90a07e1",
"productndc": "51655-397",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "077614",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "6.25MG",
"product_no": "001",
"approval_date": "Sep 5, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "12.5MG",
"product_no": "002",
"approval_date": "Sep 5, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "003",
"approval_date": "Sep 5, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "3.125MG",
"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": "ANDA077614",
"marketing_category": "ANDA",
"nonproprietary_name": "Carvedilol",
"start_marketing_date": "20200708",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code C07AG02.
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