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United States · US · US:31722-659_375cacf2-f8c1-96f1-e063-6394a90ad2df

levocetirizine dihydrochloride

Orange BookUNIISPLATC R06AE09

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

Identification

ManufacturerCamber Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeR06AE09
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    3172265931
    1 BOTTLE in 1 CARTON (31722-659-31) / 148 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
SOD6A38AGA
LEVOCETIRIZINE DIHYDROCHLORIDE
RxCUI 402349
Orange Book
A210914
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": "31722-659_375cacf2-f8c1-96f1-e063-6394a90ad2df",
  "productndc": "31722-659",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "210914",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "2.5MG/5ML",
        "product_no": "001",
        "approval_date": "Apr 1, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LEVOCETIRIZINE DIHYDROCHLORIDE",
  "proprietary_name": "levocetirizine dihydrochloride",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA210914",
  "marketing_category": "ANDA",
  "nonproprietary_name": "levocetirizine dihydrochloride",
  "start_marketing_date": "20190401",
  "active_numerator_strength": "2.5"
}

Related drugs

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