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United States · US · US:51660-754_0ea6e88f-9c46-1fe5-e063-6394a90ae867

Childrens Loratadine

Orange BookUNIISPLATC R06AX13

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

Identification

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

Packs · 1

  • ndc11
    5166075431
    3 BLISTER PACK in 1 CARTON (51660-754-31) / 10 TABLET, CHEWABLE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A210088
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": {
    "436c0126-4ff3-c082-e063-6294a90a3d72": {
      "match": "brand_token",
      "title": "CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [KESIN PHARMA CORPORATION]",
      "spl_version": "2",
      "published_date": "2026-06-01"
    }
  },
  "productid": "51660-754_0ea6e88f-9c46-1fe5-e063-6394a90ae867",
  "productndc": "51660-754",
  "dosage_form": "TABLET, CHEWABLE",
  "orange_book": {
    "appl_no": "210088",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Apr 16, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Apr 25, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LORATADINE",
  "proprietary_name": "Childrens Loratadine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA210088",
  "marketing_category": "ANDA",
  "nonproprietary_name": "LORATADINE",
  "start_marketing_date": "20180630",
  "active_numerator_strength": "5"
}

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