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United States · US · US:68196-475_c1765b31-cc97-4f6e-bb57-d90f16b73a15
Members Mark Childrens Cetirizine
Orange BookUNIISPLATC R06AE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSam's West Inc
CountryUS (United States)
ATC codeR06AE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168196475432 BOTTLE in 1 CARTON (68196-475-43) / 240 mL in 1 BOTTLE (68196-475-34)
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": {
"69adad06-48f7-40d5-bca1-ae8e50ab1646": {
"match": "brand_token",
"title": "MEMBERS MARK NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [SAM'S WEST INC]",
"spl_version": "5",
"published_date": "2026-04-20"
}
},
"productid": "68196-475_c1765b31-cc97-4f6e-bb57-d90f16b73a15",
"productndc": "68196-475",
"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": "Members Mark Childrens Cetirizine",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA204226",
"marketing_category": "ANDA",
"nonproprietary_name": "Cetirizine Hydrochloride",
"start_marketing_date": "20240923",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code R06AE.
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