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United States · US · US:72789-440_4d7b0386-3253-2606-e063-6294a90a668b

CARVEDILOL

Orange BookUNIISPLATC C07AG02

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerPD-Rx Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeC07AG02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7278944090
    90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-440-90)
  • ndc11
    7278944093
    180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-440-93)

Annotations

UNII (FDA Substance ID)
0K47UL67F2
CARVEDILOL
RxCUI 20352
Orange Book
A078165
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": "72789-440_4d7b0386-3253-2606-e063-6294a90a668b",
  "productndc": "72789-440",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078165",
    "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": "ANDA078165",
  "marketing_category": "ANDA",
  "nonproprietary_name": "CARVEDILOL",
  "start_marketing_date": "20210729",
  "active_numerator_strength": "25"
}

Related drugs

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