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United States · US · US:71335-2391_18eab889-2148-4233-aca0-38b185d5934d

Loratadine

Orange BookUNIISPLATC R06AX13

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeR06AX13
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 9

  • ndc11
    7133523911
    20 TABLET in 1 BOTTLE (71335-2391-1)
  • ndc11
    7133523912
    30 TABLET in 1 BOTTLE (71335-2391-2)
  • ndc11
    7133523913
    60 TABLET in 1 BOTTLE (71335-2391-3)
  • ndc11
    7133523914
    14 TABLET in 1 BOTTLE (71335-2391-4)
  • ndc11
    7133523915
    10 TABLET in 1 BOTTLE (71335-2391-5)
  • ndc11
    7133523916
    90 TABLET in 1 BOTTLE (71335-2391-6)
  • ndc11
    7133523917
    28 TABLET in 1 BOTTLE (71335-2391-7)
  • ndc11
    7133523918
    15 TABLET in 1 BOTTLE (71335-2391-8)
  • ndc11
    7133523919
    100 TABLET in 1 BOTTLE (71335-2391-9)

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": "71335-2391_18eab889-2148-4233-aca0-38b185d5934d",
  "productndc": "71335-2391",
  "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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