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United States · US · US:11523-6655_4523713e-42b4-1ee9-e063-6394a90abb7d

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 · 9

  • ndc11
    1152366551
    1 BLISTER PACK in 1 POUCH (11523-6655-1) / 1 TABLET in 1 BLISTER PACK
  • ndc11
    1152366552
    1 BOTTLE in 1 CARTON (11523-6655-2) / 70 TABLET in 1 BOTTLE
  • ndc11
    1152366553
    2 BOTTLE in 1 BLISTER PACK (11523-6655-3) / 45 TABLET in 1 BOTTLE
  • ndc11
    1152366554
    1 BOTTLE in 1 BLISTER PACK (11523-6655-4) / 105 TABLET in 1 BOTTLE
  • ndc11
    1152366555
    1 BOTTLE in 1 CARTON (11523-6655-5) / 60 TABLET in 1 BOTTLE
  • ndc11
    1152366556
    1 BOTTLE in 1 BLISTER PACK (11523-6655-6) / 105 TABLET in 1 BOTTLE
  • ndc11
    1152366557
    25 POUCH in 1 BOX (11523-6655-7) / 1 TABLET in 1 POUCH
  • ndc11
    1152366558
    1 BOTTLE in 1 CARTON (11523-6655-8) / 30 TABLET in 1 BOTTLE
  • ndc11
    1152366559
    1 BOTTLE in 1 CARTON (11523-6655-9) / 80 TABLET in 1 BOTTLE

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": "11523-6655_4523713e-42b4-1ee9-e063-6394a90abb7d",
  "productndc": "11523-6655",
  "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": "19930412",
  "active_numerator_strength": "10"
}

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