Cetirizine Hydrochloride (Allergy)

Orange BookUNIISPLATC R06AE

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

Identification

ManufacturerCVS Pharmacy, Inc.

CountryUS (United States)

ATC codeR06AE

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 7

ndc11
6984223701
1 BLISTER PACK in 1 CARTON (69842-237-01) / 14 TABLET in 1 BLISTER PACK
ndc11
6984223709
1 BOTTLE in 1 CARTON (69842-237-09) / 30 TABLET in 1 BOTTLE
ndc11
6984223717
1 BOTTLE in 1 CARTON (69842-237-17) / 45 TABLET in 1 BOTTLE
ndc11
6984223719
1 BOTTLE in 1 CARTON (69842-237-19) / 90 TABLET in 1 BOTTLE
ndc11
6984223723
1 BOTTLE in 1 CARTON (69842-237-23) / 120 TABLET in 1 BOTTLE
ndc11
6984223739
365 TABLET in 1 BOTTLE (69842-237-39)
ndc11
6984223745
2 BOTTLE in 1 CARTON (69842-237-45) / 120 TABLET in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

64O047KTOA

CETIRIZINE HYDROCHLORIDE

RxCUI 203150

Orange Book

A090760

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": "69842-237_621f3d87-d69e-41e6-8ece-22099cb87c01",
  "productndc": "69842-237",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "090760",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Aug 5, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Aug 5, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "003",
        "approval_date": "Aug 5, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "004",
        "approval_date": "Aug 5, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CETIRIZINE HYDROCHLORIDE",
  "proprietary_name": "Cetirizine Hydrochloride (Allergy)",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA090760",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cetirizine Hydrochloride",
  "start_marketing_date": "20190726",
  "active_numerator_strength": "10"
}

Related drugs

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