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United States · US · US:68462-163_5f5b2d20-cc2a-4e91-b2b9-260e7438ab2c
Carvedilol
Orange BookUNIISPLATC C07AG02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGlenmark Pharmaceuticals Inc., USA
CountryUS (United States)
ATC codeC07AG02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc116846216301100 TABLET, FILM COATED in 1 BOTTLE (68462-163-01)
- ndc116846216305500 TABLET, FILM COATED in 1 BOTTLE (68462-163-05)
- ndc1168462163101000 TABLET, FILM COATED in 1 BOTTLE (68462-163-10)
- ndc116846216318180 TABLET, FILM COATED in 1 BOTTLE (68462-163-18)
- ndc11684621636060 TABLET, FILM COATED in 1 BOTTLE (68462-163-60)
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": "68462-163_5f5b2d20-cc2a-4e91-b2b9-260e7438ab2c",
"productndc": "68462-163",
"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": "6.25"
}Related drugs
Other records sharing ATC code C07AG02.
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