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United States · US · US:83939-0009_42a116a8-78f8-3c52-e063-6394a90a31d9

Childrens Cetirizine Hydrochloride

Orange BookUNIISPLATC R06AE

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerVERITYRX, LLC
CountryUS (United States)
ATC codeR06AE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    8393900091
    5 mL in 1 CUP, UNIT-DOSE (83939-0009-1)
  • ndc11
    8393900092
    10 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (83939-0009-2) / 5 mL in 1 CUP, UNIT-DOSE
  • ndc11
    8393900093
    40 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (83939-0009-3) / 5 mL in 1 CUP, UNIT-DOSE
  • ndc11
    8393900094
    50 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (83939-0009-4) / 5 mL in 1 CUP, UNIT-DOSE
  • ndc11
    8393900095
    100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (83939-0009-5) / 5 mL in 1 CUP, UNIT-DOSE

Annotations

UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
A090182
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": {
    "436c0126-4ff3-c082-e063-6294a90a3d72": {
      "match": "brand_token",
      "title": "CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [KESIN PHARMA CORPORATION]",
      "spl_version": "2",
      "published_date": "2026-06-01"
    }
  },
  "productid": "83939-0009_42a116a8-78f8-3c52-e063-6394a90a31d9",
  "productndc": "83939-0009",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "090182",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG/5ML",
        "product_no": "001",
        "approval_date": "Apr 22, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG/5ML",
        "product_no": "002",
        "approval_date": "Apr 22, 2008"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CETIRIZINE HYDROCHLORIDE",
  "proprietary_name": "Childrens Cetirizine Hydrochloride",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA090182",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cetirizine Hydrochloride",
  "start_marketing_date": "20110908",
  "active_numerator_strength": "1"
}

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