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United States · US · US:51672-2085_29a536a0-3fbe-c35f-e063-6394a90ae1e3

Childrens Loratadine

Orange BookUNIISPLATC R06AX13

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

Identification

ManufacturerTaro Pharmaceuticals U.S.A., Inc.
CountryUS (United States)
ATC codeR06AX13
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    5167220851
    1 BOTTLE in 1 CARTON (51672-2085-1) / 240 mL in 1 BOTTLE
  • ndc11
    5167220854
    1 BOTTLE in 1 CARTON (51672-2085-4) / 60 mL in 1 BOTTLE
  • ndc11
    5167220855
    1 BOTTLE in 1 CARTON (51672-2085-5) / 180 mL in 1 BOTTLE
  • ndc11
    5167220858
    1 BOTTLE in 1 CARTON (51672-2085-8) / 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": "51672-2085_29a536a0-3fbe-c35f-e063-6394a90ae1e3",
  "productndc": "51672-2085",
  "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": "20040820",
  "active_numerator_strength": "5"
}

Related drugs

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