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United States · US · US:69238-2579_7bae176f-58e3-4d75-9609-80079f391e1e
Carvedilol Phosphate
Orange BookUNIISPLATC C07AG02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals NY LLC
CountryUS (United States)
ATC codeC07AG02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc116923825791100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69238-2579-1)
- ndc1169238257921000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69238-2579-2)
- ndc11692382579330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69238-2579-3)
- ndc11692382579990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69238-2579-9)
Annotations
UNII (FDA Substance ID)
EQT531S367
CARVEDILOL PHOSPHATE
RxCUI 668310
Orange Book
A204717
ABABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "EQT531S367",
"rxcui": "668310",
"inchikey": "LHNYXTULDSJZRB-UHFFFAOYSA-N",
"display_name": "CARVEDILOL PHOSPHATE",
"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": "69238-2579_7bae176f-58e3-4d75-9609-80079f391e1e",
"productndc": "69238-2579",
"dosage_form": "CAPSULE, EXTENDED RELEASE",
"orange_book": {
"appl_no": "204717",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "May 7, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "002",
"approval_date": "May 7, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "40MG",
"product_no": "003",
"approval_date": "May 7, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "80MG",
"product_no": "004",
"approval_date": "May 7, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CARVEDILOL PHOSPHATE",
"proprietary_name": "Carvedilol Phosphate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA204717",
"marketing_category": "ANDA",
"nonproprietary_name": "Carvedilol Phosphate",
"start_marketing_date": "20230801",
"active_numerator_strength": "40"
}Related drugs
Other records sharing ATC code C07AG02.
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