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United States · US · US:63868-132_2f9f8dc0-8034-445c-b7b0-bf680a6be979
Quality Choice Cetirizine Hydrochloride
Orange BookUNIISPLATC R06AE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerChain Drug Marketing Association Inc.
CountryUS (United States)
ATC codeR06AE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11638681321414 TABLET in 1 BLISTER PACK (63868-132-14)
- ndc11638681323030 TABLET in 1 BOTTLE (63868-132-30)
- ndc11638681329090 TABLET in 1 BOTTLE (63868-132-90)
Annotations
UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
A077498
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": {
"d8fd8102-114f-415d-9083-f98a63f9d1b3": {
"match": "brand_token",
"title": "QUALITY CHOICE EARWAX REMOVAL DROPS (CARBAMIDE PEROXIDE) LIQUID [CHAIN DRUG MARKETING ASSOCIATION, INC.]",
"spl_version": "4",
"published_date": "2026-06-01"
}
},
"productid": "63868-132_2f9f8dc0-8034-445c-b7b0-bf680a6be979",
"productndc": "63868-132",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "077498",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "5MG",
"product_no": "001",
"approval_date": "Dec 27, 2007"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG",
"product_no": "002",
"approval_date": "Dec 27, 2007"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "5MG",
"product_no": "003",
"approval_date": "Dec 27, 2007"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG",
"product_no": "004",
"approval_date": "Dec 27, 2007"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "CETIRIZINE HYDROCHLORIDE",
"proprietary_name": "Quality Choice Cetirizine Hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA077498",
"marketing_category": "ANDA",
"nonproprietary_name": "Cetirizine Hydrochloride",
"start_marketing_date": "20071227",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code R06AE.
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