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United States · US · US:59779-204_f3cca5a2-319c-42d3-b655-3b01b9785c12
Pseudoephedrine Hydrochloride
Orange BookUNIISPLATC R01BA52
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCVS Pharmacy
CountryUS (United States)
ATC codeR01BA52
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11597792042120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (59779-204-21)
- ndc11597792046910 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (59779-204-69)
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": "59779-204_f3cca5a2-319c-42d3-b655-3b01b9785c12",
"productndc": "59779-204",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"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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