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United States · US · US:42571-312_2e504864-a08d-48e1-e063-6394a90a92ed

Levocetirizine Dihydrochloride

Orange BookUNIISPLATC R06AE09

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

Identification

ManufacturerMicro Labs Limited
CountryUS (United States)
ATC codeR06AE09
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    4257131211
    100 BLISTER PACK in 1 CARTON (42571-312-11) / 10 TABLET in 1 BLISTER PACK (42571-312-32)
  • ndc11
    4257131218
    1 BOTTLE in 1 CARTON (42571-312-18) / 10 TABLET in 1 BOTTLE
  • ndc11
    4257131253
    2500 TABLET in 1 POUCH (42571-312-53)
  • ndc11
    4257131290
    1 BOTTLE in 1 CARTON (42571-312-90) / 90 TABLET in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
SOD6A38AGA
LEVOCETIRIZINE DIHYDROCHLORIDE
RxCUI 402349
Orange Book
A211551
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": "42571-312_2e504864-a08d-48e1-e063-6394a90a92ed",
  "productndc": "42571-312",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "211551",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Nov 20, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LEVOCETIRIZINE DIHYDROCHLORIDE",
  "proprietary_name": "Levocetirizine Dihydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA211551",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Levocetirizine Dihydrochloride",
  "start_marketing_date": "20190201",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code R06AE09.

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