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 · 13

ndc11
5511169904
1 BOTTLE in 1 CARTON (55111-699-04) / 120 TABLET, FILM COATED in 1 BOTTLE
ndc11
5511169915
1 BLISTER PACK in 1 CARTON (55111-699-15) / 14 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
5511169919
1 BOTTLE in 1 CARTON (55111-699-19) / 175 TABLET, FILM COATED in 1 BOTTLE
ndc11
5511169930
1 BOTTLE in 1 CARTON (55111-699-30) / 30 TABLET, FILM COATED in 1 BOTTLE
ndc11
5511169931
1 BOTTLE in 1 CARTON (55111-699-31) / 300 TABLET, FILM COATED in 1 BOTTLE
ndc11
5511169945
1 BOTTLE in 1 CARTON (55111-699-45) / 45 TABLET, FILM COATED in 1 BOTTLE
ndc11
5511169947
2 BOTTLE in 1 CARTON (55111-699-47) / 175 TABLET, FILM COATED in 1 BOTTLE
ndc11
5511169951
1 BOTTLE in 1 CARTON (55111-699-51) / 75 TABLET, FILM COATED in 1 BOTTLE
ndc11
5511169952
1 BOTTLE in 1 CARTON (55111-699-52) / 14 TABLET, FILM COATED in 1 BOTTLE
ndc11
5511169960
1 BOTTLE in 1 CARTON (55111-699-60) / 60 TABLET, FILM COATED in 1 BOTTLE
ndc11
5511169973
1 BOTTLE in 1 CARTON (55111-699-73) / 365 TABLET, FILM COATED in 1 BOTTLE
ndc11
5511169974
2 BLISTER PACK in 1 CARTON (55111-699-74) / 7 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
5511169990
90 TABLET, FILM COATED in 1 BOTTLE (55111-699-90)

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": "55111-699_000d3a47-3836-b678-9487-2bbc518cd57f",
  "productndc": "55111-699",
  "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"
}

Related drugs

Other records sharing ATC code R06AE.

Access this data programmatically

Query Cetirizine Hydrochloride and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs