🇺🇸
United States · US · US:45802-107_a8ebb0c0-4ab7-4bf2-a8e3-09e62c3cdcd7
pseudoephedrine hydrochloride
Orange BookUNIISPLATC R01BA52
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPadagis Israel Pharmaceuticals Ltd
CountryUS (United States)
ATC codeR01BA52
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11458021075210 BLISTER PACK in 1 CARTON (45802-107-52) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
6V9V2RYJ8N
PSEUDOEPHEDRINE HYDROCHLORIDE
RxCUI 91168
Orange Book
A075153
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "6V9V2RYJ8N",
"rxcui": "91168",
"inchikey": "BALXUFOVQVENIU-KXNXZCPBSA-N",
"display_name": "PSEUDOEPHEDRINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"3bf95c58-4fd9-4caa-a54f-2e61a5eacae8": {
"match": "brand_token",
"title": "PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED [STRATEGIC SOURCING SERVICES LLC]",
"spl_version": "2",
"published_date": "2026-05-11"
}
},
"productid": "45802-107_a8ebb0c0-4ab7-4bf2-a8e3-09e62c3cdcd7",
"productndc": "45802-107",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "075153",
"products": [
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "120MG",
"product_no": "001",
"approval_date": "Feb 26, 1999"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "PSEUDOEPHEDRINE HYDROCHLORIDE",
"proprietary_name": "pseudoephedrine hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA075153",
"marketing_category": "ANDA",
"nonproprietary_name": "Pseudoephedrine HCl",
"start_marketing_date": "20140524",
"active_numerator_strength": "120"
}Related drugs
Other records sharing ATC code R01BA52.
Access this data programmatically
Query 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.