🇺🇸
United States · US · US:68196-204_b22ca9ba-71ee-41a5-8395-85eeea13f4a4
Pseudoephedrine hydrochloride
Orange BookUNIISPLATC R01BA52
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSAM'S WEST INC
CountryUS (United States)
ATC codeR01BA52
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168196204202 BLISTER PACK in 1 PACKAGE (68196-204-20) / 10 TABLET, FILM COATED in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
6V9V2RYJ8N
PSEUDOEPHEDRINE HYDROCHLORIDE
RxCUI 91168
Orange Book
A077442
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": "68196-204_b22ca9ba-71ee-41a5-8395-85eeea13f4a4",
"productndc": "68196-204",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "077442",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "120MG",
"product_no": "001",
"approval_date": "Sep 28, 2005"
}
],
"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": "ANDA077442",
"marketing_category": "ANDA",
"nonproprietary_name": "Pseudoephedrine hydrochloride",
"start_marketing_date": "20120207",
"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.