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United States · US · US:37808-131_3c5477aa-2b46-b58a-e063-6294a90aeaf5

Childrens Loratadine

Orange BookUNIISPLATC R06AX13

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

Identification

ManufacturerH E B
CountryUS (United States)
ATC codeR06AX13
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    3780813108
    1 BOTTLE in 1 CARTON (37808-131-08) / 120 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A076805
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": "37808-131_3c5477aa-2b46-b58a-e063-6294a90aeaf5",
  "productndc": "37808-131",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "076805",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1MG/ML",
        "product_no": "001",
        "approval_date": "Aug 20, 2004"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LORATADINE",
  "proprietary_name": "Childrens Loratadine",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA076805",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Loratadine",
  "start_marketing_date": "20170317",
  "active_numerator_strength": "5"
}

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