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United States · US · US:21130-526_5ef0c05a-40de-40cb-b52c-3f1ab96a5348

Loratadine

Orange BookUNIISPLATC R06AX13

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

Identification

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

Packs · 5

  • ndc11
    2113052613
    1 BOTTLE in 1 CARTON (21130-526-13) / 120 TABLET in 1 BOTTLE
  • ndc11
    2113052631
    3 BLISTER PACK in 1 CARTON (21130-526-31) / 10 TABLET in 1 BLISTER PACK
  • ndc11
    2113052638
    1 BOTTLE in 1 CARTON (21130-526-38) / 365 TABLET in 1 BOTTLE
  • ndc11
    2113052643
    1 BOTTLE in 1 CARTON (21130-526-43) / 45 TABLET in 1 BOTTLE
  • ndc11
    2113052669
    1 BLISTER PACK in 1 CARTON (21130-526-69) / 10 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A076134
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": "21130-526_5ef0c05a-40de-40cb-b52c-3f1ab96a5348",
  "productndc": "21130-526",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "076134",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Aug 18, 2003"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LORATADINE",
  "proprietary_name": "Loratadine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA076134",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Loratadine",
  "start_marketing_date": "20090606",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code R06AX13.

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