Cetirizine Hydrochloride

Orange BookUNIISPLATC R06AE

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeR06AE

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 9

ndc11
7133596121
30 TABLET, FILM COATED in 1 BOTTLE (71335-9612-1)
ndc11
7133596122
14 TABLET, FILM COATED in 1 BOTTLE (71335-9612-2)
ndc11
7133596123
7 TABLET, FILM COATED in 1 BOTTLE (71335-9612-3)
ndc11
7133596124
10 TABLET, FILM COATED in 1 BOTTLE (71335-9612-4)
ndc11
7133596125
15 TABLET, FILM COATED in 1 BOTTLE (71335-9612-5)
ndc11
7133596126
90 TABLET, FILM COATED in 1 BOTTLE (71335-9612-6)
ndc11
7133596127
20 TABLET, FILM COATED in 1 BOTTLE (71335-9612-7)
ndc11
7133596128
60 TABLET, FILM COATED in 1 BOTTLE (71335-9612-8)
ndc11
7133596129
100 TABLET, FILM COATED in 1 BOTTLE (71335-9612-9)

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": "71335-9612_feff9aa9-70f0-4e25-a822-f219cd1dde9a",
  "productndc": "71335-9612",
  "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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