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United States · US · US:76385-135_4cddb5b7-a38f-4360-9e37-f67386f05e55

Nadolol

Orange BookUNIISPLATC C07AA12

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

Identification

ManufacturerUNICHEM PHARMACEUTICALS (USA), INC.
CountryUS (United States)
ATC codeC07AA12
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7638513501
    100 TABLET in 1 BOTTLE (76385-135-01)
  • ndc11
    7638513510
    1000 TABLET in 1 BOTTLE (76385-135-10)

Annotations

UNII (FDA Substance ID)
FEN504330V
NADOLOL
RxCUI 7226
Orange Book
A210955
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "FEN504330V",
    "rxcui": "7226",
    "inchikey": "VWPOSFSPZNDTMJ-UCWKZMIHSA-N",
    "display_name": "NADOLOL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "c154d99c-e4fb-41d0-8fac-e1982672e8d7": {
      "match": "brand_token",
      "title": "NADOLOL TABLET [BRYANT RANCH PREPACK]",
      "spl_version": "103",
      "published_date": "2026-06-01"
    }
  },
  "productid": "76385-135_4cddb5b7-a38f-4360-9e37-f67386f05e55",
  "productndc": "76385-135",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "210955",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Jul 23, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "002",
        "approval_date": "Jul 23, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "80MG",
        "product_no": "003",
        "approval_date": "Jul 23, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NADOLOL",
  "proprietary_name": "Nadolol",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA210955",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nadolol",
  "start_marketing_date": "20190726",
  "active_numerator_strength": "80"
}

Related drugs

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