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United States · US · US:10135-763_43e1e645-7da5-86de-e063-6394a90a7f3a

Loratadine Allergy Relief

Orange BookUNIISPLATC R06AX13

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

Identification

ManufacturerMarlex Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeR06AX13
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    1013576303
    300 TABLET in 1 BOTTLE (10135-763-03)
  • ndc11
    1013576330
    30 TABLET in 1 BOTTLE (10135-763-30)
  • ndc11
    1013576390
    90 TABLET in 1 BOTTLE (10135-763-90)

Annotations

UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A076134
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": {
    "d778c4d2-184a-4dc8-9351-66d81d0618f2": {
      "match": "brand_token",
      "title": "LORATADINE TABLET [PREFERRED PHARMACEUTICALS INC.]",
      "spl_version": "3",
      "published_date": "2026-06-01"
    }
  },
  "productid": "10135-763_43e1e645-7da5-86de-e063-6394a90a7f3a",
  "productndc": "10135-763",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "076134",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Aug 18, 2003"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LORATADINE",
  "proprietary_name": "Loratadine Allergy Relief",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA076134",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Loratadine",
  "start_marketing_date": "20221001",
  "active_numerator_strength": "10"
}

Related drugs

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