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United States · US · US:25000-092_aa667b5f-a4ac-4129-bae9-f9c1de776629

Loratadine 10mg

Orange BookUNIISPLATC R06AX13

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

Identification

ManufacturerMARKSANS PHARMA LIMITED
CountryUS (United States)
ATC codeR06AX13
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    2500009203
    1 BOTTLE in 1 CARTON (25000-092-03) / 30 TABLET in 1 BOTTLE
  • ndc11
    2500009279
    1 BOTTLE in 1 CARTON (25000-092-79) / 150 TABLET in 1 BOTTLE
  • ndc11
    2500009280
    365 TABLET in 1 BOTTLE (25000-092-80)
  • ndc11
    2500009281
    2 BLISTER PACK in 1 CARTON (25000-092-81) / 7 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A219223
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": "25000-092_aa667b5f-a4ac-4129-bae9-f9c1de776629",
  "productndc": "25000-092",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "219223",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Nov 21, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LORATADINE",
  "proprietary_name": "Loratadine 10mg",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA219223",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Loratadine 10mg",
  "start_marketing_date": "20241121",
  "active_numerator_strength": "10"
}

Related drugs

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