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United States · US · US:71335-2026_320bb66b-2b98-4114-9d37-77ff5da834b0

CARVEDILOL

Orange BookUNIISPLATC C07AG02

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeC07AG02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 7

  • ndc11
    7133520261
    30 TABLET, FILM COATED in 1 BOTTLE (71335-2026-1)
  • ndc11
    7133520262
    60 TABLET, FILM COATED in 1 BOTTLE (71335-2026-2)
  • ndc11
    7133520263
    100 TABLET, FILM COATED in 1 BOTTLE (71335-2026-3)
  • ndc11
    7133520264
    90 TABLET, FILM COATED in 1 BOTTLE (71335-2026-4)
  • ndc11
    7133520265
    120 TABLET, FILM COATED in 1 BOTTLE (71335-2026-5)
  • ndc11
    7133520266
    180 TABLET, FILM COATED in 1 BOTTLE (71335-2026-6)
  • ndc11
    7133520267
    10 TABLET, FILM COATED in 1 BOTTLE (71335-2026-7)

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": "71335-2026_320bb66b-2b98-4114-9d37-77ff5da834b0",
  "productndc": "71335-2026",
  "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": "12.5"
}

Related drugs

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