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United States · US · US:0904-5833_3e4ab498-9f9e-bd3b-e063-6294a90a9b9c

Loratadine and Pseudoephedrine Sulfate

Orange BookUNIISPLATC R06AX

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

Identification

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

Packs · 2

  • ndc11
    0904583315
    10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0904-5833-15)
  • ndc11
    0904583348
    15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0904-5833-48)

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": "0904-5833_3e4ab498-9f9e-bd3b-e063-6294a90a9b9c",
  "productndc": "0904-5833",
  "dosage_form": "TABLET, FILM COATED, 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 Sulfate",
  "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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