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United States · US · US:70264-030_43c8f3f3-5cc5-a286-e063-6294a90a6192

Claritin

Orange BookUNIISPLATC R06AX13

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

Identification

ManufacturerR J General Corporation
CountryUS (United States)
ATC codeR06AX13
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7026403001
    25 POUCH in 1 CARTON (70264-030-01) / 1 TABLET in 1 POUCH

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": "70264-030_43c8f3f3-5cc5-a286-e063-6294a90a6192",
  "productndc": "70264-030",
  "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": "20210301",
  "active_numerator_strength": "10"
}

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