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United States · US · US:84324-027_042dab86-b69d-4b03-bd6a-539232ef56f6

Nuvicare-Allergy Relief Loratadine Tablets, 10 mg

Orange BookUNIISPLATC R06AX13

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

Identification

ManufacturerNUVICARE LLC
CountryUS (United States)
ATC codeR06AX13
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8432402701
    100 TABLET in 1 BOTTLE (84324-027-01)

Annotations

UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A214684
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "7AJO3BO7QN",
    "rxcui": "28889",
    "inchikey": "JCCNYMKQOSZNPW-UHFFFAOYSA-N",
    "display_name": "LORATADINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "023a46f0-8d1c-4f62-953d-3e6458a54f6e": {
      "match": "brand_token",
      "title": "NUVICARE-ALLERGY RELIEF LORATADINE TABLETS, 10 MG (LORATADINE) TABLET [NUVICARE LLC]",
      "spl_version": "1",
      "published_date": "2025-07-03"
    }
  },
  "productid": "84324-027_042dab86-b69d-4b03-bd6a-539232ef56f6",
  "productndc": "84324-027",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "214684",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Jan 7, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LORATADINE",
  "proprietary_name": "Nuvicare-Allergy Relief Loratadine Tablets, 10 mg",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA214684",
  "marketing_category": "ANDA",
  "nonproprietary_name": "loratadine",
  "start_marketing_date": "20250701",
  "active_numerator_strength": "10"
}

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