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United States · US · US:37808-102_44787388-9e5a-cc35-e063-6394a90a1072
HEB
Orange BookUNIISPLATC R06AE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerH E B
CountryUS (United States)
ATC codeR06AE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1137808102081 BOTTLE in 1 CARTON (37808-102-08) / 120 mL in 1 BOTTLE
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": {
"b76c3591-6383-4661-b3db-7a56b11202f7": {
"match": "brand_token",
"title": "HEB EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [HEB]",
"spl_version": "15",
"published_date": "2026-01-12"
}
},
"productid": "37808-102_44787388-9e5a-cc35-e063-6394a90a1072",
"productndc": "37808-102",
"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": "HEB",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA090182",
"marketing_category": "ANDA",
"nonproprietary_name": "Cetirizine Hydrochloride",
"start_marketing_date": "20110908",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code R06AE.
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