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United States · US · US:58602-818_cfa8d72c-3d1a-464c-b63a-b7b7525c1a3c

Loratadine

Orange BookUNIISPLATC R06AX13

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

Identification

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

Packs · 5

  • ndc11
    5860281805
    5 BLISTER PACK in 1 CARTON (58602-818-05) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
  • ndc11
    5860281808
    4 BLISTER PACK in 1 CARTON (58602-818-08) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
  • ndc11
    5860281867
    2 BLISTER PACK in 1 CARTON (58602-818-67) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
  • ndc11
    5860281883
    1 BLISTER PACK in 1 CARTON (58602-818-83) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
  • ndc11
    5860281884
    3 BLISTER PACK in 1 CARTON (58602-818-84) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A211900
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": "58602-818_cfa8d72c-3d1a-464c-b63a-b7b7525c1a3c",
  "productndc": "58602-818",
  "dosage_form": "CAPSULE, LIQUID FILLED",
  "orange_book": {
    "appl_no": "211900",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Mar 24, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LORATADINE",
  "proprietary_name": "Loratadine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA211900",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Loratadine",
  "start_marketing_date": "20230324",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code R06AX13.

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