CARVEDILOL

Orange BookUNIISPLATC C07AG02

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeC07AG02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 8

ndc11
7133520331
30 TABLET, FILM COATED in 1 BOTTLE (71335-2033-1)
ndc11
7133520332
60 TABLET, FILM COATED in 1 BOTTLE (71335-2033-2)
ndc11
7133520333
100 TABLET, FILM COATED in 1 BOTTLE (71335-2033-3)
ndc11
7133520334
180 TABLET, FILM COATED in 1 BOTTLE (71335-2033-4)
ndc11
7133520335
90 TABLET, FILM COATED in 1 BOTTLE (71335-2033-5)
ndc11
7133520336
120 TABLET, FILM COATED in 1 BOTTLE (71335-2033-6)
ndc11
7133520337
25 TABLET, FILM COATED in 1 BOTTLE (71335-2033-7)
ndc11
7133520338
10 TABLET, FILM COATED in 1 BOTTLE (71335-2033-8)

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": "71335-2033_7a32817e-04ec-4e29-8b03-1120393abd81",
  "productndc": "71335-2033",
  "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": "6.25"
}

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