Cetirizine Hydrochloride (Allergy)

Orange BookUNIISPLATC R06AE

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

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeR06AE

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 12

ndc11
7120570000
100 TABLET in 1 BOTTLE (71205-700-00)
ndc11
7120570006
6 TABLET in 1 BOTTLE (71205-700-06)
ndc11
7120570010
10 TABLET in 1 BOTTLE (71205-700-10)
ndc11
7120570012
12 TABLET in 1 BOTTLE (71205-700-12)
ndc11
7120570014
14 TABLET in 1 BOTTLE (71205-700-14)
ndc11
7120570015
15 TABLET in 1 BOTTLE (71205-700-15)
ndc11
7120570020
20 TABLET in 1 BOTTLE (71205-700-20)
ndc11
7120570021
21 TABLET in 1 BOTTLE (71205-700-21)
ndc11
7120570030
30 TABLET in 1 BOTTLE (71205-700-30)
ndc11
7120570060
60 TABLET in 1 BOTTLE (71205-700-60)
ndc11
7120570072
120 TABLET in 1 BOTTLE (71205-700-72)
ndc11
7120570090
90 TABLET in 1 BOTTLE (71205-700-90)

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": "71205-700_c5844e33-c337-4b62-91ca-de3d388b7d45",
  "productndc": "71205-700",
  "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": "20150805",
  "active_numerator_strength": "10"
}

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