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United States · US · US:0904-6754_a689a700-468b-45ac-8849-371a604587f4
SudoGest 12 Hour
Orange BookUNIISPLATC R01BA52
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMajor Pharmaceuticals
CountryUS (United States)
ATC codeR01BA52
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11090467541510 BLISTER PACK in 1 CARTON (0904-6754-15) / 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": {
"7cd8f7f3-c262-4f7c-bcaf-068be2c952f9": {
"match": "brand_token",
"title": "SUDOGEST (CHLORPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL) TABLET [MAJOR PHARMACEUTICALS]",
"spl_version": "22",
"published_date": "2026-04-03"
}
},
"productid": "0904-6754_a689a700-468b-45ac-8849-371a604587f4",
"productndc": "0904-6754",
"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": "SudoGest 12 Hour",
"active_ingred_unit": "mg/1",
"application_number": "ANDA075153",
"marketing_category": "ANDA",
"nonproprietary_name": "Pseudoephedrine HCl",
"start_marketing_date": "20190212",
"active_numerator_strength": "120"
}Related drugs
Other records sharing ATC code R01BA52.
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