Cetirizine Hydrochloride

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 · 6

ndc11
7120570900
100 TABLET, FILM COATED in 1 BOTTLE (71205-709-00)
ndc11
7120570906
6 TABLET, FILM COATED in 1 BOTTLE (71205-709-06)
ndc11
7120570910
10 TABLET, FILM COATED in 1 BOTTLE (71205-709-10)
ndc11
7120570920
20 TABLET, FILM COATED in 1 BOTTLE (71205-709-20)
ndc11
7120570930
30 TABLET, FILM COATED in 1 BOTTLE (71205-709-30)
ndc11
7120570990
90 TABLET, FILM COATED in 1 BOTTLE (71205-709-90)

Annotations

UNII (FDA Substance ID)

64O047KTOA

CETIRIZINE HYDROCHLORIDE

RxCUI 203150

Orange Book

A078343

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": "71205-709_bb392ca5-d39d-4265-95b2-bc44e133101b",
  "productndc": "71205-709",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078343",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Jan 15, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Jan 15, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "003",
        "approval_date": "Jan 15, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG",
        "product_no": "004",
        "approval_date": "Jan 15, 2008"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CETIRIZINE HYDROCHLORIDE",
  "proprietary_name": "Cetirizine Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078343",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cetirizine Hydrochloride Tablets",
  "start_marketing_date": "20181217",
  "active_numerator_strength": "10"
}

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