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United States · US · US:71335-2551_99fa3280-671d-46b4-8b66-94b9171c9ad7

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
    7133525511
    20 TABLET in 1 BOTTLE (71335-2551-1)
  • ndc11
    7133525512
    30 TABLET in 1 BOTTLE (71335-2551-2)
  • ndc11
    7133525513
    60 TABLET in 1 BOTTLE (71335-2551-3)
  • ndc11
    7133525514
    14 TABLET in 1 BOTTLE (71335-2551-4)
  • ndc11
    7133525515
    10 TABLET in 1 BOTTLE (71335-2551-5)
  • ndc11
    7133525516
    90 TABLET in 1 BOTTLE (71335-2551-6)
  • ndc11
    7133525517
    28 TABLET in 1 BOTTLE (71335-2551-7)
  • ndc11
    7133525518
    15 TABLET in 1 BOTTLE (71335-2551-8)
  • ndc11
    7133525519
    100 TABLET in 1 BOTTLE (71335-2551-9)

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": "71335-2551_99fa3280-671d-46b4-8b66-94b9171c9ad7",
  "productndc": "71335-2551",
  "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 PRESCRIPTION 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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