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United States · US · US:23155-929_ef266d70-f451-4938-b720-2103625cd384
Cetirizine hydrochloride
Orange BookUNIISPLATC R06AE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHeritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.
CountryUS (United States)
ATC codeR06AE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc112315592951120 mL in 1 BOTTLE (23155-929-51)
- ndc112315592952473 mL in 1 BOTTLE (23155-929-52)
Annotations
UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
A078876
AA
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": "23155-929_ef266d70-f451-4938-b720-2103625cd384",
"productndc": "23155-929",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "078876",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "5MG/5ML",
"product_no": "001",
"approval_date": "May 11, 2012"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CETIRIZINE HYDROCHLORIDE",
"proprietary_name": "Cetirizine hydrochloride",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA078876",
"marketing_category": "ANDA",
"nonproprietary_name": "Cetirizine hydrochloride",
"start_marketing_date": "20250301",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code R06AE.
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