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United States · US · US:11523-0101_4526da60-c33b-fb4a-e063-6294a90a8692

Claritin

Orange BookUNIISPLATC R06AX13

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

Identification

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

Packs · 3

  • ndc11
    1152301011
    1 BOTTLE in 1 CARTON (11523-0101-1) / 30 mL in 1 BOTTLE
  • ndc11
    1152301012
    1 BOTTLE in 1 CARTON (11523-0101-2) / 80 mL in 1 BOTTLE
  • ndc11
    1152301013
    1 BOTTLE in 1 CARTON (11523-0101-3) / 240 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
N020641
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": "11523-0101_4526da60-c33b-fb4a-e063-6294a90a8692",
  "productndc": "11523-0101",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "020641",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1MG/ML",
        "product_no": "002",
        "approval_date": "Nov 27, 2002"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "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/mL",
  "application_number": "NDA020641",
  "marketing_category": "NDA",
  "nonproprietary_name": "loratadine",
  "start_marketing_date": "20240522",
  "active_numerator_strength": "1"
}

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