🇺🇸
United States · US · US:0536-1279_cf50d4ee-e05e-477a-b543-4ba232e53c80
Rugby Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride
Orange BookUNIISPLATC R06AE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRugby Laboratories
CountryUS (United States)
ATC codeR06AE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11053612791212 BLISTER PACK in 1 CARTON (0536-1279-12) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
- ndc11053612793524 BLISTER PACK in 1 CARTON (0536-1279-35) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
A210719
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": {
"50c46cf5-3e64-9e0f-e063-6294a90a2317": {
"match": "brand_token",
"title": "RUGBY ANTIFUNGAL (TOLNAFTATE AEROSOL, POWDER) AEROSOL, SPRAY [RUGBY LABORATORIES]",
"spl_version": "2",
"published_date": "2026-05-20"
}
},
"productid": "0536-1279_cf50d4ee-e05e-477a-b543-4ba232e53c80",
"productndc": "0536-1279",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "210719",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "5MG;120MG",
"product_no": "001",
"approval_date": "Nov 16, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE",
"proprietary_name": "Rugby Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA210719",
"marketing_category": "ANDA",
"nonproprietary_name": "Cetirizine hydrochloride, Pseudoephedrine hydrochloride",
"start_marketing_date": "20200309",
"active_numerator_strength": "5; 120"
}Related drugs
Other records sharing ATC code R06AE.
Access this data programmatically
Query Rugby Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride 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.