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United States · US · US:63629-2533_acc7fd37-12cc-4319-ac53-eb35e3e18d04

levocetirizine dihydrochloride

Orange BookUNIISPLATC R06AE09

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeR06AE09
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6362925331
    1 BOTTLE in 1 CARTON (63629-2533-1) / 148 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
SOD6A38AGA
LEVOCETIRIZINE DIHYDROCHLORIDE
RxCUI 402349
Orange Book
A091263
AA
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": {
    "8274ca80-e7d3-4f4f-9901-cc5c589b4fef": {
      "match": "brand_token",
      "title": "LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]",
      "spl_version": "102",
      "published_date": "2026-05-25"
    }
  },
  "productid": "63629-2533_acc7fd37-12cc-4319-ac53-eb35e3e18d04",
  "productndc": "63629-2533",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "091263",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "2.5MG/5ML",
        "product_no": "001",
        "approval_date": "Nov 7, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LEVOCETIRIZINE DIHYDROCHLORIDE",
  "proprietary_name": "levocetirizine dihydrochloride",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA091263",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Levocetirizine dihydrochloride",
  "start_marketing_date": "20111107",
  "active_numerator_strength": ".5"
}

Related drugs

Other records sharing ATC code R06AE09.

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