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 · 7

ndc11
5860281204
10 BLISTER PACK in 1 CARTON (58602-812-04) / 10 TABLET in 1 BLISTER PACK (58602-812-83)
ndc11
5860281209
1 BOTTLE in 1 CARTON (58602-812-09) / 30 TABLET in 1 BOTTLE
ndc11
5860281217
1 BOTTLE in 1 CARTON (58602-812-17) / 45 TABLET in 1 BOTTLE
ndc11
5860281223
1 BOTTLE in 1 CARTON (58602-812-23) / 120 TABLET in 1 BOTTLE
ndc11
5860281239
1 BOTTLE in 1 CARTON (58602-812-39) / 365 TABLET in 1 BOTTLE
ndc11
5860281241
1000 TABLET in 1 BOTTLE (58602-812-41)
ndc11
5860281299
75 TABLET in 1 PACKAGE, COMBINATION (58602-812-99)

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": "58602-812_146cd9eb-d2c1-4424-9e37-350004f18507",
  "productndc": "58602-812",
  "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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