Cetirizine Hydrochloride (Allergy)

Orange BookUNIISPLATC R06AE

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

Identification

ManufacturerAurohealth LLC

CountryUS (United States)

ATC codeR06AE

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 14

ndc11
5860244501
1 BLISTER PACK in 1 CARTON (58602-445-01) / 14 TABLET in 1 BLISTER PACK
ndc11
5860244509
1 BOTTLE in 1 CARTON (58602-445-09) / 30 TABLET in 1 BOTTLE
ndc11
5860244515
1 BOTTLE in 1 CARTON (58602-445-15) / 60 TABLET in 1 BOTTLE
ndc11
5860244517
1 BOTTLE in 1 CARTON (58602-445-17) / 45 TABLET in 1 BOTTLE
ndc11
5860244519
1 BOTTLE in 1 CARTON (58602-445-19) / 90 TABLET in 1 BOTTLE
ndc11
5860244521
10 BLISTER PACK in 1 CARTON (58602-445-21) / 10 TABLET in 1 BLISTER PACK
ndc11
5860244538
1 BOTTLE in 1 CARTON (58602-445-38) / 300 TABLET in 1 BOTTLE
ndc11
5860244540
500 TABLET in 1 BOTTLE (58602-445-40)
ndc11
5860244541
1000 TABLET in 1 BOTTLE (58602-445-41)
ndc11
5860244547
75 TABLET in 1 PACKAGE, COMBINATION (58602-445-47)
ndc11
5860244554
1 BOTTLE in 1 CARTON (58602-445-54) / 70 TABLET in 1 BOTTLE
ndc11
5860244560
1 BLISTER PACK in 1 CARTON (58602-445-60) / 5 TABLET in 1 BLISTER PACK
ndc11
5860244565
2 BLISTER PACK in 1 CARTON (58602-445-65) / 7 TABLET in 1 BLISTER PACK
ndc11
5860244594
1 BOTTLE in 1 CARTON (58602-445-94) / 100 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": "58602-445_146cd9eb-d2c1-4424-9e37-350004f18507",
  "productndc": "58602-445",
  "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": "20150805",
  "active_numerator_strength": "10"
}

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