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United States · US · US:11822-9990_ccbdd53a-d690-4df0-ad4b-13806b44f1aa

Loratadine and Pseudoephedrine

Orange BookUNIISPLATC R06AX

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

Identification

ManufacturerRite Aid
CountryUS (United States)
ATC codeR06AX
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    1182299900
    1 BLISTER PACK in 1 CARTON (11822-9990-0) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • ndc11
    1182299905
    1 BLISTER PACK in 1 CARTON (11822-9990-5) / 15 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A076557
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": "11822-9990_ccbdd53a-d690-4df0-ad4b-13806b44f1aa",
  "productndc": "11822-9990",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "076557",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG;240MG",
        "product_no": "001",
        "approval_date": "Sep 22, 2004"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LORATADINE; PSEUDOEPHEDRINE SULFATE",
  "proprietary_name": "Loratadine and Pseudoephedrine",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA076557",
  "marketing_category": "ANDA",
  "nonproprietary_name": "LORATADINE and PSEUDOEPHEDRINE SULFATE",
  "start_marketing_date": "20041117",
  "active_numerator_strength": "10; 240"
}

Related drugs

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