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United States · US · US:69168-475_1307fce8-d753-4df5-90f0-a902befdfe35

Loratadine 10mg

Orange BookUNIISPLATC R06AX13

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

Identification

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

Packs · 8

  • ndc11
    6916847502
    150 TABLET in 1 BOTTLE (69168-475-02)
  • ndc11
    6916847505
    500 TABLET in 1 BOTTLE (69168-475-05)
  • ndc11
    6916847508
    1 BLISTER PACK in 1 CARTON (69168-475-08) / 5 TABLET in 1 BLISTER PACK
  • ndc11
    6916847509
    1 BLISTER PACK in 1 CARTON (69168-475-09) / 10 TABLET in 1 BLISTER PACK
  • ndc11
    6916847517
    300 TABLET in 1 BOTTLE (69168-475-17)
  • ndc11
    6916847530
    1 BOTTLE in 1 CARTON (69168-475-30) / 30 TABLET in 1 BOTTLE
  • ndc11
    6916847560
    60 TABLET in 1 BOTTLE (69168-475-60)
  • ndc11
    6916847599
    365 TABLET in 1 BOTTLE (69168-475-99)

Annotations

UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A211718
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": {
    "d778c4d2-184a-4dc8-9351-66d81d0618f2": {
      "match": "brand_token",
      "title": "LORATADINE TABLET [PREFERRED PHARMACEUTICALS INC.]",
      "spl_version": "3",
      "published_date": "2026-06-01"
    }
  },
  "productid": "69168-475_1307fce8-d753-4df5-90f0-a902befdfe35",
  "productndc": "69168-475",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "211718",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Jul 28, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LORATADINE",
  "proprietary_name": "Loratadine 10mg",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA211718",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Loratadine 10mg",
  "start_marketing_date": "20250318",
  "active_numerator_strength": "10"
}

Related drugs

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