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United States · US · US:57483-950_d91b9ee4-dbd2-459c-a789-a59b7bf61d0e

Allervarx

Orange BookUNIISPLATC R06AX13

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

Identification

ManufacturerInnovus Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeR06AX13
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5748395010
    3 BLISTER PACK in 1 CARTON (57483-950-10) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A213294
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": {
    "ec4d1e77-6995-4228-8e63-a9ab6232dace": {
      "match": "brand_token",
      "title": "ALLERVARX (LORATADINE) TABLET, ORALLY DISINTEGRATING [INNOVUS PHARMACEUTICALS, INC.]",
      "spl_version": "3",
      "published_date": "2024-12-30"
    }
  },
  "productid": "57483-950_d91b9ee4-dbd2-459c-a789-a59b7bf61d0e",
  "productndc": "57483-950",
  "dosage_form": "TABLET, ORALLY DISINTEGRATING",
  "orange_book": {
    "appl_no": "213294",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Oct 30, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LORATADINE",
  "proprietary_name": "Allervarx",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA213294",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Loratadine",
  "start_marketing_date": "20220530",
  "active_numerator_strength": "10"
}

Related drugs

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