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United States · US · US:63187-100_91a17d89-5112-4176-bfa0-9fd2d27922c5

Loratadine Allergy Relief

Orange BookUNIISPLATC R06AX13

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeR06AX13
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    6318710010
    10 TABLET in 1 BOTTLE (63187-100-10)
  • ndc11
    6318710020
    20 TABLET in 1 BOTTLE (63187-100-20)
  • ndc11
    6318710030
    30 TABLET in 1 BOTTLE (63187-100-30)
  • ndc11
    6318710090
    90 TABLET in 1 BOTTLE (63187-100-90)

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": "63187-100_91a17d89-5112-4176-bfa0-9fd2d27922c5",
  "productndc": "63187-100",
  "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 Allergy Relief",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA076134",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Loratadine",
  "start_marketing_date": "20030828",
  "active_numerator_strength": "10"
}

Related drugs

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