🇺🇸
United States · US · US:68016-165_39ad746e-1dd7-f3fb-e063-6394a90a767d
Premier Value
Orange BookUNIISPLATC R06AE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPharmacy Value Alliance LLC
CountryUS (United States)
ATC codeR06AE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168016165001 BOTTLE in 1 CARTON (68016-165-00) / 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": {
"e16d0256-1151-8394-e053-2995a90ab56c": {
"match": "brand_token",
"title": "PREMIER SOLUTIONS LIQUID CORN AND CALLUS REMOVER (SALICYLIC ACID) LIQUID [PREMIER BRANDS OF AMERICA INC.]",
"spl_version": "6",
"published_date": "2026-05-11"
}
},
"productid": "68016-165_39ad746e-1dd7-f3fb-e063-6394a90a767d",
"productndc": "68016-165",
"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": "Premier Value",
"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.
Access this data programmatically
Query Premier Value and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.