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United States · US · US:50090-5554_3b6c8d9e-78df-44be-9bc6-052e19f97706
Pseudoephedrine hydrochloride
Orange BookUNIISPLATC R01BA52
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeR01BA52
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11500905554010 TABLET, FILM COATED in 1 BLISTER PACK (50090-5554-0)
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": "50090-5554_3b6c8d9e-78df-44be-9bc6-052e19f97706",
"productndc": "50090-5554",
"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": "20060428",
"active_numerator_strength": "120"
}Related drugs
Other records sharing ATC code R01BA52.
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