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United States · US · US:0363-2108_ebfab224-98d3-435a-9812-1f16b9b1e8d9

Childrens Walitin

Orange BookUNIISPLATC R06AX13

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

Identification

ManufacturerWalgreen Company
CountryUS (United States)
ATC codeR06AX13
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0363210808
    1 BOTTLE in 1 CARTON (0363-2108-08) / 120 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A201865
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": "0363-2108_ebfab224-98d3-435a-9812-1f16b9b1e8d9",
  "productndc": "0363-2108",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "201865",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1MG/ML",
        "product_no": "001",
        "approval_date": "Jul 31, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LORATADINE",
  "proprietary_name": "Childrens Walitin",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA201865",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Loratadine",
  "start_marketing_date": "20161212",
  "active_numerator_strength": "5"
}

Related drugs

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