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United States · US · US:50090-4629_51527d7c-26f4-4538-928e-f3ac2bba4f84
Sudafed Sinus Congestion 12 Hour
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
- ndc1150090462901 BLISTER PACK in 1 CARTON (50090-4629-0) / 10 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": {
"67428f4b-28be-4682-a9a9-781bf85089ff": {
"match": "brand_token",
"title": "SUDAFED PE SINUS PRESSURE PLUS PAIN (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [SPORTPHARM LLC]",
"spl_version": "1",
"published_date": "2026-03-12"
}
},
"productid": "50090-4629_51527d7c-26f4-4538-928e-f3ac2bba4f84",
"productndc": "50090-4629",
"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": "Sudafed Sinus Congestion 12 Hour",
"active_ingred_unit": "mg/1",
"application_number": "ANDA075153",
"marketing_category": "ANDA",
"nonproprietary_name": "Pseudoephedrine Hydrochloride",
"start_marketing_date": "20190617",
"active_numerator_strength": "120"
}Related drugs
Other records sharing ATC code R01BA52.
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