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United States · US · US:69452-211_932678d1-e6bf-4154-ac00-b6b9c9fbd16e

LORATADINE

Orange BookUNIISPLATC R06AX13

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

Identification

ManufacturerBionpharma Inc.
CountryUS (United States)
ATC codeR06AX13
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    6945221103
    1 BOTTLE in 1 CARTON (69452-211-03) / 5 CAPSULE, LIQUID FILLED in 1 BOTTLE
  • ndc11
    6945221107
    1 BLISTER PACK in 1 CARTON (69452-211-07) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
  • ndc11
    6945221116
    1 BOTTLE in 1 CARTON (69452-211-16) / 50 CAPSULE, LIQUID FILLED in 1 BOTTLE
  • ndc11
    6945221126
    1 BOTTLE in 1 CARTON (69452-211-26) / 200 CAPSULE, LIQUID FILLED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A202538
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": "69452-211_932678d1-e6bf-4154-ac00-b6b9c9fbd16e",
  "productndc": "69452-211",
  "dosage_form": "CAPSULE, LIQUID FILLED",
  "orange_book": {
    "appl_no": "202538",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Dec 21, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LORATADINE",
  "proprietary_name": "LORATADINE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA202538",
  "marketing_category": "ANDA",
  "nonproprietary_name": "LORATADINE",
  "start_marketing_date": "20190301",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code R06AX13.

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