Levocetirizine Dihydrochloride

Orange BookUNIISPLATC R06AE09

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerWalmart Inc.

CountryUS (United States)

ATC codeR06AE09

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
4903549210
1 BOTTLE in 1 CARTON (49035-492-10) / 10 TABLET, COATED in 1 BOTTLE
ndc11
4903549212
1 BOTTLE in 1 CARTON (49035-492-12) / 120 TABLET, COATED in 1 BOTTLE
ndc11
4903549235
1 BOTTLE in 1 BOTTLE (49035-492-35) / 35 TABLET, COATED in 1 BOTTLE
ndc11
4903549279
2 BLISTER PACK in 1 BLISTER PACK (49035-492-79) / 5 TABLET, COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

SOD6A38AGA

LEVOCETIRIZINE DIHYDROCHLORIDE

RxCUI 402349

Orange Book

A210375

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": "49035-492_faf3eee1-908d-7d25-bfaf-14c26daabcf7",
  "productndc": "49035-492",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "210375",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Jan 19, 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": "ANDA210375",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Levocetirizine Dihydrochloride",
  "start_marketing_date": "20190726",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code R06AE09.

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