Carvedilol

Orange BookUNIISPLATC C07AG02

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

Identification

ManufacturerUNICHEM PHARMACEUTICALS (USA), INC.

CountryUS (United States)

ATC codeC07AG02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
7638511101
100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76385-111-01)
ndc11
7638511150
500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76385-111-50)

Annotations

UNII (FDA Substance ID)

0K47UL67F2

CARVEDILOL

RxCUI 20352

Orange Book

A078384

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": "76385-111_4aa597d4-9141-4bef-a4d5-03b111958338",
  "productndc": "76385-111",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078384",
    "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": "ANDA078384",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Carvedilol",
  "start_marketing_date": "20161001",
  "active_numerator_strength": "6.25"
}

Related drugs

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