Levocetirizine Dihydrochloride

Orange BookUNIISPLATC R06AE09

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

Identification

ManufacturerCamber Consumer Care Inc

CountryUS (United States)

ATC codeR06AE09

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
6923032101
10 BLISTER PACK in 1 CARTON (69230-321-01) / 10 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
6923032110
1000 TABLET, FILM COATED in 1 BOTTLE (69230-321-10)
ndc11
6923032131
1 BOTTLE in 1 CARTON (69230-321-31) / 35 TABLET, FILM COATED in 1 BOTTLE
ndc11
6923032132
1 BOTTLE in 1 CARTON (69230-321-32) / 55 TABLET, FILM COATED in 1 BOTTLE
ndc11
6923032133
1 BOTTLE in 1 CARTON (69230-321-33) / 80 TABLET, FILM COATED in 1 BOTTLE
ndc11
6923032134
1 BOTTLE in 1 CARTON (69230-321-34) / 180 TABLET, FILM COATED 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": {
    "8274ca80-e7d3-4f4f-9901-cc5c589b4fef": {
      "match": "brand_token",
      "title": "LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]",
      "spl_version": "102",
      "published_date": "2026-05-25"
    }
  },
  "productid": "69230-321_7ca0cee0-b628-4266-b361-ad5c52b6f11e",
  "productndc": "69230-321",
  "dosage_form": "TABLET, FILM COATED",
  "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": "Levocetirizine Dihydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA213513",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Levocetirizine Dihydrochloride",
  "start_marketing_date": "20201028",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code R06AE09.

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