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United States · US · US:67751-153_f5db87e3-16ba-4e7e-e053-2995a90ab04e

Claritin

Orange BookUNIISPLATC R06AX13

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

Identification

ManufacturerNavajo Manufacturing Company
CountryUS (United States)
ATC codeR06AX13
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 0

No packs registered.

Annotations

UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
N019658
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": {
    "8e14b61f-faf6-43a8-a080-75f64514217a": {
      "match": "brand_token",
      "title": "CLARITIN LIQUI-GELS (LORATADINE) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC.]",
      "spl_version": "13",
      "published_date": "2026-02-09"
    }
  },
  "productid": "67751-153_f5db87e3-16ba-4e7e-e053-2995a90ab04e",
  "productndc": "67751-153",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "019658",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Nov 27, 2002"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "10MG",
        "product_no": "003",
        "approval_date": "Nov 19, 2003"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LORATADINE",
  "proprietary_name": "Claritin",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA019658",
  "marketing_category": "NDA",
  "nonproprietary_name": "loratadine",
  "start_marketing_date": "20171204",
  "active_numerator_strength": "10"
}

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