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United States · US · US:71335-1463_06540a82-d48f-46df-bf2c-04e8332ba9ce
Carvedilol
Orange BookUNIISPLATC C07AG02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeC07AG02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc117133514631100 TABLET, FILM COATED in 1 BOTTLE (71335-1463-1)
- ndc11713351463230 TABLET, FILM COATED in 1 BOTTLE (71335-1463-2)
- ndc11713351463390 TABLET, FILM COATED in 1 BOTTLE (71335-1463-3)
- ndc11713351463460 TABLET, FILM COATED in 1 BOTTLE (71335-1463-4)
- ndc117133514635120 TABLET, FILM COATED in 1 BOTTLE (71335-1463-5)
- ndc117133514636180 TABLET, FILM COATED in 1 BOTTLE (71335-1463-6)
Annotations
UNII (FDA Substance ID)
0K47UL67F2
CARVEDILOL
RxCUI 20352
Orange Book
A078251
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": "71335-1463_06540a82-d48f-46df-bf2c-04e8332ba9ce",
"productndc": "71335-1463",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "078251",
"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": "ANDA078251",
"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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