Cetrizine Hydrochloride

Orange BookUNIISPLATC R06AE

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

Identification

ManufacturerAPOZEAL PHARMACEUTICALS INC

CountryUS (United States)

ATC codeR06AE

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
8374518804
1 BOTTLE in 1 CARTON (83745-188-04) / 118 mL in 1 BOTTLE
ndc11
8374518808
1 BOTTLE in 1 CARTON (83745-188-08) / 237 mL in 1 BOTTLE
ndc11
8374518812
120 mL in 1 BOTTLE, PLASTIC (83745-188-12)
ndc11
8374518816
1 BOTTLE in 1 CARTON (83745-188-16) / 473 mL in 1 BOTTLE
ndc11
8374518824
240 mL in 1 BOTTLE, PLASTIC (83745-188-24)
ndc11
8374518848
480 mL in 1 BOTTLE, PLASTIC (83745-188-48)

Annotations

UNII (FDA Substance ID)

64O047KTOA

CETIRIZINE HYDROCHLORIDE

RxCUI 203150

Orange Book

A090474

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": {
    "9c0549cf-4c93-45d9-9eac-3948fa45554e": {
      "match": "brand_token",
      "title": "CETRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE) SOLUTION [APOZEAL PHARMACEUTICALS INC]",
      "spl_version": "5",
      "published_date": "2026-05-20"
    }
  },
  "productid": "83745-188_6b714ab7-ee3a-4b6a-ab4b-de3c2b2b2499",
  "productndc": "83745-188",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "090474",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG/5ML",
        "product_no": "001",
        "approval_date": "Mar 30, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG/5ML",
        "product_no": "002",
        "approval_date": "Mar 30, 2009"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CETIRIZINE HYDROCHLORIDE",
  "proprietary_name": "Cetrizine Hydrochloride",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA090474",
  "marketing_category": "ANDA",
  "nonproprietary_name": "CETIRIZINE HYDROCHLORIDE",
  "start_marketing_date": "20250101",
  "active_numerator_strength": "1"
}

Related drugs

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