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United States · US · US:82725-0142_42292076-863b-8cc2-e063-6294a90ae709

Loratadine

Orange BookUNIISPLATC R06AX13

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

Identification

ManufacturerCabinet Health P.B.C.
CountryUS (United States)
ATC codeR06AX13
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    8272501421
    8000 TABLET in 1 BAG (82725-0142-1)
  • ndc11
    8272501422
    1 BAG in 1 DRUM (82725-0142-2) / 100000 TABLET in 1 BAG
  • ndc11
    8272501423
    10000 TABLET in 1 BAG (82725-0142-3)
  • ndc11
    8272501424
    1 DRUM in 1 DRUM (82725-0142-4) / 96000 TABLET in 1 DRUM

Annotations

UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A214684
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": "82725-0142_42292076-863b-8cc2-e063-6294a90ae709",
  "productndc": "82725-0142",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "214684",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Jan 7, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LORATADINE",
  "proprietary_name": "Loratadine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA214684",
  "marketing_category": "ANDA",
  "nonproprietary_name": "LORATADINE",
  "start_marketing_date": "20251001",
  "active_numerator_strength": "10"
}

Related drugs

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