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United States · US · US:72888-500_4b7daf77-d3f7-0b55-e063-6394a90a84fc
Carvedilol
Orange BookUNIISPLATC C07AG02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAdvagen Pharma Limited
CountryUS (United States)
ATC codeC07AG02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc117288850001100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72888-500-01)
- ndc117288850002500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72888-500-02)
- ndc1172888500031000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72888-500-03)
Annotations
UNII (FDA Substance ID)
0K47UL67F2
CARVEDILOL
RxCUI 20352
Orange Book
A078786
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": "72888-500_4b7daf77-d3f7-0b55-e063-6394a90a84fc",
"productndc": "72888-500",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "078786",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "3.125MG",
"product_no": "001",
"approval_date": "Dec 22, 2009"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "6.25MG",
"product_no": "002",
"approval_date": "Dec 22, 2009"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "12.5MG",
"product_no": "003",
"approval_date": "Dec 22, 2009"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "004",
"approval_date": "Dec 22, 2009"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CARVEDILOL",
"proprietary_name": "Carvedilol",
"active_ingred_unit": "mg/1",
"application_number": "ANDA078786",
"marketing_category": "ANDA",
"nonproprietary_name": "Carvedilol",
"start_marketing_date": "20250917",
"active_numerator_strength": "6.25"
}Related drugs
Other records sharing ATC code C07AG02.
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