Cetirizine Hydrochloride (Allergy)

Orange BookUNIISPLATC R06AE

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

Identification

ManufacturerPreferred Pharmaceuticals Inc.

CountryUS (United States)

ATC codeR06AE

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
6878882040
100 TABLET in 1 BOTTLE (68788-8204-0)
ndc11
6878882041
14 TABLET in 1 BOTTLE (68788-8204-1)
ndc11
6878882043
30 TABLET in 1 BOTTLE (68788-8204-3)
ndc11
6878882045
15 TABLET in 1 BOTTLE (68788-8204-5)
ndc11
6878882046
60 TABLET in 1 BOTTLE (68788-8204-6)
ndc11
6878882049
90 TABLET in 1 BOTTLE (68788-8204-9)

Annotations

UNII (FDA Substance ID)

64O047KTOA

CETIRIZINE HYDROCHLORIDE

RxCUI 203150

Orange Book

A090760

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "64O047KTOA",
    "rxcui": "203150",
    "inchikey": "PGLIUCLTXOYQMV-UHFFFAOYSA-N",
    "display_name": "CETIRIZINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "817d07cf-5e31-421f-9e95-943bae01f5b0": {
      "match": "brand_token",
      "title": "CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC]",
      "spl_version": "8",
      "published_date": "2026-06-01"
    }
  },
  "productid": "68788-8204_ec89e868-59e4-4bbd-8c95-5cf56f7df9ce",
  "productndc": "68788-8204",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "090760",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Aug 5, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Aug 5, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "003",
        "approval_date": "Aug 5, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "004",
        "approval_date": "Aug 5, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CETIRIZINE HYDROCHLORIDE",
  "proprietary_name": "Cetirizine Hydrochloride (Allergy)",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA090760",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cetirizine Hydrochloride",
  "start_marketing_date": "20220401",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code R06AE.

Access this data programmatically

Query Cetirizine Hydrochloride (Allergy) and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs