Cetirizine Hydrochloride

Orange BookUNIISPLATC R06AE

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

Identification

ManufacturerDr.Reddy's Laboratories Limited

CountryUS (United States)

ATC codeR06AE

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 8

ndc11
5511135104
1 BOTTLE in 1 CARTON (55111-351-04) / 120 TABLET, FILM COATED in 1 BOTTLE
ndc11
5511135130
1 BOTTLE in 1 CARTON (55111-351-30) / 30 TABLET, FILM COATED in 1 BOTTLE
ndc11
5511135145
1 BOTTLE in 1 CARTON (55111-351-45) / 45 TABLET, FILM COATED in 1 BOTTLE
ndc11
5511135147
2 BOTTLE in 1 CARTON (55111-351-47) / 175 TABLET, FILM COATED in 1 BOTTLE
ndc11
5511135151
1 BOTTLE in 1 CARTON (55111-351-51) / 75 TABLET, FILM COATED in 1 BOTTLE
ndc11
5511135160
1 BOTTLE in 1 CARTON (55111-351-60) / 60 TABLET, FILM COATED in 1 BOTTLE
ndc11
5511135174
2 BLISTER PACK in 1 CARTON (55111-351-74) / 7 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
5511135190
1 BOTTLE in 1 CARTON (55111-351-90) / 90 TABLET, FILM COATED in 1 BOTTLE

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": "55111-351_000d3a47-3836-b678-9487-2bbc518cd57f",
  "productndc": "55111-351",
  "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",
  "start_marketing_date": "20080115",
  "active_numerator_strength": "10"
}

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