🇺🇸
United States · US · US:62756-915_a0bd1e9b-eb9f-46e7-8cee-10bde092d7cb
Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride
Orange BookUNIISPLATC R06AE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeR06AE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1162756915622 BLISTER PACK in 1 CARTON (62756-915-62) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (62756-915-60)
- ndc1162756915734 BLISTER PACK in 1 CARTON (62756-915-73) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (62756-915-60)
Annotations
UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
A090922
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": "62756-915_a0bd1e9b-eb9f-46e7-8cee-10bde092d7cb",
"productndc": "62756-915",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "090922",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "5MG;120MG",
"product_no": "001",
"approval_date": "Sep 28, 2012"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE",
"proprietary_name": "Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA090922",
"marketing_category": "ANDA",
"nonproprietary_name": "Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride",
"start_marketing_date": "20120929",
"active_numerator_strength": "5; 120"
}Related drugs
Other records sharing ATC code R06AE.
Access this data programmatically
Query 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.