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United States · US · US:80070-100_b349557d-e1ba-435d-b0db-1cdce853b418

Alavert

Orange BookUNIISPLATC R06AX

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

Identification

ManufacturerFoundation Consumer Brands
CountryUS (United States)
ATC codeR06AX
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    8007010012
    2 BLISTER PACK in 1 CARTON (80070-100-12) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
  • ndc11
    8007010024
    4 BLISTER PACK in 1 CARTON (80070-100-24) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A076050
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": {
    "f741d1cf-0ecb-4405-8596-07af394537db": {
      "match": "brand_token",
      "title": "ALAVERT ALLERGY (LORATADINE) TABLET, ORALLY DISINTEGRATING [FOUNDATION CONSUMER BRANDS]",
      "spl_version": "4",
      "published_date": "2026-02-25"
    }
  },
  "productid": "80070-100_b349557d-e1ba-435d-b0db-1cdce853b418",
  "productndc": "80070-100",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "076050",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG;120MG",
        "product_no": "001",
        "approval_date": "Jan 30, 2003"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LORATADINE; PSEUDOEPHEDRINE SULFATE",
  "proprietary_name": "Alavert",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA076050",
  "marketing_category": "ANDA",
  "nonproprietary_name": "LORATADINE and PSEUDOEPHEDRINE SULFATE",
  "start_marketing_date": "20211215",
  "active_numerator_strength": "5; 120"
}

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