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United States · US · US:85766-117_50322360-43ae-7232-e063-6394a90ae5f8

MEDIQUE Loradamed

Orange BookUNIISPLATC R06AX13

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

Identification

ManufacturerSportpharm LLC
CountryUS (United States)
ATC codeR06AX13
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    8576611712
    10 PACKET in 1 BOX (85766-117-12) / 1 TABLET, FILM COATED in 1 PACKET (85766-117-46)
  • ndc11
    8576611746
    1 TABLET, FILM COATED in 1 PACKET (85766-117-46)
  • ndc11
    8576611750
    50 PACKET in 1 BOX (85766-117-50) / 1 TABLET, FILM COATED in 1 PACKET (85766-117-46)

Annotations

UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A076134
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": {
    "f01adfcc-b32a-4a98-a4e7-2ce87b824b5a": {
      "match": "brand_token",
      "title": "MEDIQUE MEDIPROXEN (NAPROXEN SODIUM) TABLET, FILM COATED [SPORTPHARM LLC]",
      "spl_version": "2",
      "published_date": "2026-04-27"
    }
  },
  "productid": "85766-117_50322360-43ae-7232-e063-6394a90ae5f8",
  "productndc": "85766-117",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "076134",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Aug 18, 2003"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LORATADINE",
  "proprietary_name": "MEDIQUE Loradamed",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA076134",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Loratadine",
  "start_marketing_date": "20081230",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code R06AX13.

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