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United States · US · US:59556-917_0df1189a-9973-e8b7-e063-6294a90a61a3

LORATADINE

Orange BookUNIISPLATC R06AX13

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

Identification

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

Packs · 6

  • ndc11
    5955691701
    1 BLISTER PACK in 1 CARTON (59556-917-01) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
  • ndc11
    5955691702
    2 BLISTER PACK in 1 CARTON (59556-917-02) / 20 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
  • ndc11
    5955691703
    3 BLISTER PACK in 1 CARTON (59556-917-03) / 30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
  • ndc11
    5955691704
    4 BLISTER PACK in 1 CARTON (59556-917-04) / 40 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
  • ndc11
    5955691705
    5 BLISTER PACK in 1 CARTON (59556-917-05) / 50 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
  • ndc11
    5955691706
    6 BLISTER PACK in 1 CARTON (59556-917-06) / 60 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A213294
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": "59556-917_0df1189a-9973-e8b7-e063-6294a90a61a3",
  "productndc": "59556-917",
  "dosage_form": "TABLET, ORALLY DISINTEGRATING",
  "orange_book": {
    "appl_no": "213294",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Oct 30, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LORATADINE",
  "proprietary_name": "LORATADINE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA213294",
  "marketing_category": "ANDA",
  "nonproprietary_name": "LORATADINE",
  "start_marketing_date": "20210810",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code R06AX13.

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