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United States · US · US:69230-323_04d9c5a8-1f42-f7c0-e063-6294a90a92ae

Loratadine

Orange BookUNIISPLATC R06AX13

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

Identification

ManufacturerCamber Consumer Care Inc
CountryUS (United States)
ATC codeR06AX13
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 6

  • ndc11
    6923032301
    10 BLISTER PACK in 1 CARTON (69230-323-01) / 10 TABLET in 1 BLISTER PACK (69230-323-32)
  • ndc11
    6923032310
    1000 TABLET in 1 BOTTLE (69230-323-10)
  • ndc11
    6923032330
    1 BOTTLE in 1 CARTON (69230-323-30) / 30 TABLET in 1 BOTTLE
  • ndc11
    6923032331
    1 BOTTLE in 1 CARTON (69230-323-31) / 108 TABLET in 1 BOTTLE
  • ndc11
    6923032333
    1 BOTTLE in 1 CARTON (69230-323-33) / 100 TABLET in 1 BOTTLE
  • ndc11
    6923032334
    1 BOTTLE in 1 CARTON (69230-323-34) / 300 TABLET in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A211718
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": "69230-323_04d9c5a8-1f42-f7c0-e063-6294a90a92ae",
  "productndc": "69230-323",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "211718",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Jul 28, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LORATADINE",
  "proprietary_name": "Loratadine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA211718",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Loratadine",
  "start_marketing_date": "20230728",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code R06AX13.

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