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United States · US · US:59556-301_0df121d3-d783-620c-e063-6294a90acdab

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
    5955630101
    1 BLISTER PACK in 1 CARTON (59556-301-01) / 10 TABLET in 1 BLISTER PACK
  • ndc11
    5955630102
    2 BLISTER PACK in 1 CARTON (59556-301-02) / 10 TABLET in 1 BLISTER PACK
  • ndc11
    5955630103
    3 BLISTER PACK in 1 CARTON (59556-301-03) / 10 TABLET in 1 BLISTER PACK
  • ndc11
    5955630104
    4 BLISTER PACK in 1 CARTON (59556-301-04) / 10 TABLET in 1 BLISTER PACK
  • ndc11
    5955630105
    5 BLISTER PACK in 1 CARTON (59556-301-05) / 10 TABLET in 1 BLISTER PACK
  • ndc11
    5955630106
    6 BLISTER PACK in 1 CARTON (59556-301-06) / 10 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A212795
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": "59556-301_0df121d3-d783-620c-e063-6294a90acdab",
  "productndc": "59556-301",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "212795",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Sep 18, 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": "ANDA212795",
  "marketing_category": "ANDA",
  "nonproprietary_name": "LORATADINE",
  "start_marketing_date": "20210810",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code R06AX13.

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