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United States · US · US:0093-0135_3d07d8c6-ffea-41c3-a50c-4e3d723de14f
Carvedilol
Orange BookUNIISPLATC C07AG02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTeva Pharmaceuticals USA, Inc.
CountryUS (United States)
ATC codeC07AG02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc110093013501100 TABLET, FILM COATED in 1 BOTTLE (0093-0135-01)
- ndc110093013505500 TABLET, FILM COATED in 1 BOTTLE (0093-0135-05)
Annotations
UNII (FDA Substance ID)
0K47UL67F2
CARVEDILOL
RxCUI 20352
Orange Book
A076373
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": "0093-0135_3d07d8c6-ffea-41c3-a50c-4e3d723de14f",
"productndc": "0093-0135",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "076373",
"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": "ANDA076373",
"marketing_category": "ANDA",
"nonproprietary_name": "Carvedilol",
"start_marketing_date": "20070906",
"active_numerator_strength": "6.25"
}Related drugs
Other records sharing ATC code C07AG02.
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