Carvedilol Phosphate

Orange BookUNIISPLATC C07AG02

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerSun Pharmaceutical Industries, Inc.

CountryUS (United States)

ATC codeC07AG02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5766466683
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (57664-666-83)

Annotations

UNII (FDA Substance ID)

EQT531S367

CARVEDILOL PHOSPHATE

RxCUI 668310

Orange Book

A090132

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": "57664-666_468e6649-e69b-4938-e063-6394a90ad7a2",
  "productndc": "57664-666",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "090132",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Oct 25, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "Oct 25, 2017"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "003",
        "approval_date": "Oct 25, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "80MG",
        "product_no": "004",
        "approval_date": "Oct 25, 2017"
      }
    ],
    "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": "ANDA090132",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Carvedilol Phosphate",
  "start_marketing_date": "20171108",
  "active_numerator_strength": "80"
}

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