CETIRIZINE HYDROCHLORIDE

Orange BookUNIISPLATC R06AE

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

Identification

ManufacturerBAJAJ MEDICAL, LLC

CountryUS (United States)

ATC codeR06AE

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
6103748002
120 mL in 1 BOTTLE, PLASTIC (61037-480-02)
ndc11
6103748003
480 mL in 1 BOTTLE, PLASTIC (61037-480-03)
ndc11
6103748004
240 mL in 1 BOTTLE, PLASTIC (61037-480-04)
ndc11
6103748006
5 mL in 1 CUP, UNIT-DOSE (61037-480-06)
ndc11
6103748012
5 mL in 1 BOX, UNIT-DOSE (61037-480-12)

Annotations

UNII (FDA Substance ID)

64O047KTOA

CETIRIZINE HYDROCHLORIDE

RxCUI 203150

Orange Book

A091327

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": "61037-480_3ba40b0a-2360-0431-e063-6394a90a285e",
  "productndc": "61037-480",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "091327",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG/5ML",
        "product_no": "001",
        "approval_date": "Oct 17, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG/5ML",
        "product_no": "002",
        "approval_date": "Oct 17, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CETIRIZINE HYDROCHLORIDE",
  "proprietary_name": "CETIRIZINE HYDROCHLORIDE",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA091327",
  "marketing_category": "ANDA",
  "nonproprietary_name": "CETIRIZINE HYDROCHLORIDE",
  "start_marketing_date": "20250508",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code R06AE.

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