Cetirizine HCl

Orange BookUNIISPLATC R06AE

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

Identification

ManufacturerGLENMARK THERAPEUTICS INC., USA

CountryUS (United States)

ATC codeR06AE

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 18

ndc11
7265712803
1 BOTTLE in 1 CARTON (72657-128-03) / 300 TABLET in 1 BOTTLE
ndc11
7265712804
1 BOTTLE in 1 CARTON (72657-128-04) / 400 TABLET in 1 BOTTLE
ndc11
7265712808
1 BOTTLE in 1 CARTON (72657-128-08) / 120 TABLET in 1 BOTTLE
ndc11
7265712814
1 BOTTLE in 1 CARTON (72657-128-14) / 140 TABLET in 1 BOTTLE
ndc11
7265712815
1 BOTTLE in 1 CARTON (72657-128-15) / 150 TABLET in 1 BOTTLE
ndc11
7265712818
1 BOTTLE in 1 CARTON (72657-128-18) / 180 TABLET in 1 BOTTLE
ndc11
7265712824
1 BOTTLE in 1 CARTON (72657-128-24) / 240 TABLET in 1 BOTTLE
ndc11
7265712830
1 BOTTLE in 1 CARTON (72657-128-30) / 30 TABLET in 1 BOTTLE
ndc11
7265712835
1 BOTTLE in 1 CARTON (72657-128-35) / 365 TABLET in 1 BOTTLE
ndc11
7265712841
1 BOTTLE in 1 CARTON (72657-128-41) / 14 TABLET in 1 BOTTLE
ndc11
7265712845
1 BOTTLE in 1 CARTON (72657-128-45) / 45 TABLET in 1 BOTTLE
ndc11
7265712860
1 BOTTLE in 1 CARTON (72657-128-60) / 60 TABLET in 1 BOTTLE
ndc11
7265712870
1 BOTTLE in 1 CARTON (72657-128-70) / 70 TABLET in 1 BOTTLE
ndc11
7265712881
2 BOTTLE in 1 CARTON (72657-128-81) / 60 TABLET in 1 BOTTLE
ndc11
7265712882
2 BOTTLE in 1 CARTON (72657-128-82) / 70 TABLET in 1 BOTTLE
ndc11
7265712884
2 BOTTLE in 1 CARTON (72657-128-84) / 90 TABLET in 1 BOTTLE
ndc11
7265712886
2 BOTTLE in 1 CARTON (72657-128-86) / 120 TABLET in 1 BOTTLE
ndc11
7265712890
1 BOTTLE in 1 CARTON (72657-128-90) / 90 TABLET in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

64O047KTOA

CETIRIZINE HYDROCHLORIDE

RxCUI 203150

Orange Book

A078427

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": "72657-128_9b19f466-3796-44b8-a637-092926c275f1",
  "productndc": "72657-128",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "078427",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG",
        "product_no": "003",
        "approval_date": "Dec 28, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "004",
        "approval_date": "Dec 28, 2007"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CETIRIZINE HYDROCHLORIDE",
  "proprietary_name": "Cetirizine HCl",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078427",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cetirizine",
  "start_marketing_date": "20240513",
  "active_numerator_strength": "5"
}

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