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United States · US · US:73581-201_450fca8a-7ac1-d5fc-e063-6394a90aec36

ALLERGY RELIEF

Orange BookUNIISPLATC R06AE09

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

Identification

ManufacturerYYBA CORP
CountryUS (United States)
ATC codeR06AE09
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7358120118
    1 BOTTLE in 1 BOX (73581-201-18) / 18 TABLET in 1 BOTTLE
  • ndc11
    7358120180
    1 BOTTLE in 1 BOX (73581-201-80) / 180 TABLET in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
SOD6A38AGA
LEVOCETIRIZINE DIHYDROCHLORIDE
RxCUI 402349
Orange Book
A213513
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "SOD6A38AGA",
    "rxcui": "402349",
    "inchikey": "PGLIUCLTXOYQMV-GHVWMZMZSA-N",
    "display_name": "LEVOCETIRIZINE DIHYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "934c7b91-3cba-47f0-8efa-77216f3f15c4": {
      "match": "brand_token",
      "title": "ALLERGY RELIEF CHILDRENS (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [AMERISOURCE BERGEN]",
      "spl_version": "14",
      "published_date": "2026-06-01"
    }
  },
  "productid": "73581-201_450fca8a-7ac1-d5fc-e063-6394a90aec36",
  "productndc": "73581-201",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "213513",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Apr 29, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LEVOCETIRIZINE DIHYDROCHLORIDE",
  "proprietary_name": "ALLERGY RELIEF",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA213513",
  "marketing_category": "ANDA",
  "nonproprietary_name": "LEVOCETIRIZINE DIHYDROCHLORIDE",
  "start_marketing_date": "20200630",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code R06AE09.

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