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United States · US · US:49738-686_6c556dbe-66fd-907c-e053-2991aa0a475d

LORATADINE

Orange BookUNIISPLATC R06AX13

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

Identification

ManufacturerSMART SENSE (KMART)
CountryUS (United States)
ATC codeR06AX13
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    4973868607
    10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (49738-686-07)
  • ndc11
    4973868630
    30 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (49738-686-30)

Annotations

UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A206214
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": "49738-686_6c556dbe-66fd-907c-e053-2991aa0a475d",
  "productndc": "49738-686",
  "dosage_form": "CAPSULE, LIQUID FILLED",
  "orange_book": {
    "appl_no": "206214",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Sep 23, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LORATADINE",
  "proprietary_name": "LORATADINE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA206214",
  "marketing_category": "ANDA",
  "nonproprietary_name": "LORATADINE",
  "start_marketing_date": "20170131",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code R06AX13.

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