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United States · US · US:17856-6765_50c2baa2-d912-32d0-e063-6394a90a01da
childrens cetirizine hydrochloride
Orange BookUNIISPLATC R06AE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerATLANTIC BIOLOGICALS CORP.
CountryUS (United States)
ATC codeR06AE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11178566765172 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-6765-1) / 5 mL in 1 CUP, UNIT-DOSE (17856-6765-2)
- ndc111785667653120 SYRINGE in 1 CASE (17856-6765-3) / 2.5 mL in 1 SYRINGE
Annotations
UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
A204226
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": "17856-6765_50c2baa2-d912-32d0-e063-6394a90a01da",
"productndc": "17856-6765",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "204226",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "5MG/5ML",
"product_no": "001",
"approval_date": "Sep 9, 2013"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "CETIRIZINE HYDROCHLORIDE",
"proprietary_name": "childrens cetirizine hydrochloride",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA204226",
"marketing_category": "ANDA",
"nonproprietary_name": "Cetirizine HCl",
"start_marketing_date": "20180822",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code R06AE.
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