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United States · US · US:68788-8659_e547e609-2932-459e-9195-216c2794c11c

Loratadine

Orange BookUNIISPLATC R06AX13

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

Identification

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

Packs · 5

  • ndc11
    6878886590
    10 TABLET in 1 BOTTLE (68788-8659-0)
  • ndc11
    6878886591
    14 TABLET in 1 BOTTLE (68788-8659-1)
  • ndc11
    6878886593
    30 TABLET in 1 BOTTLE (68788-8659-3)
  • ndc11
    6878886595
    15 TABLET in 1 BOTTLE (68788-8659-5)
  • ndc11
    6878886599
    90 TABLET in 1 BOTTLE (68788-8659-9)

Annotations

UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A210722
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": "68788-8659_e547e609-2932-459e-9195-216c2794c11c",
  "productndc": "68788-8659",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "210722",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Dec 23, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LORATADINE",
  "proprietary_name": "Loratadine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA210722",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Loratadine",
  "start_marketing_date": "20240513",
  "active_numerator_strength": "10"
}

Related drugs

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