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United States · US · US:25000-021_adf6c78c-edb1-4ffb-a934-d8cb772e621f

Loratadine

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 · 6

  • ndc11
    2500002108
    100 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-021-08)
  • ndc11
    2500002113
    600 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-021-13)
  • ndc11
    2500002121
    4 BAG in 1 BOX (25000-021-21) / 7500 CAPSULE, LIQUID FILLED in 1 BAG
  • ndc11
    2500002134
    28 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (25000-021-34)
  • ndc11
    2500002136
    3 BLISTER PACK in 1 CARTON (25000-021-36) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
  • ndc11
    2500002146
    8 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-021-46)

Annotations

UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A206214
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": "25000-021_adf6c78c-edb1-4ffb-a934-d8cb772e621f",
  "productndc": "25000-021",
  "dosage_form": "CAPSULE, LIQUID FILLED",
  "orange_book": {
    "appl_no": "206214",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Sep 23, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LORATADINE",
  "proprietary_name": "Loratadine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA206214",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Loratadine",
  "start_marketing_date": "20161001",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code R06AX13.

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