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United States · US · US:21130-158_14aa89a7-5eb1-4037-a169-cbb527b46e95
Pseudoephedrine HCl
Orange BookUNIISPLATC R01BA52
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBetter Living Brands LLC
CountryUS (United States)
ATC codeR01BA52
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1121130158672 BLISTER PACK in 1 CARTON (21130-158-67) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
6V9V2RYJ8N
PSEUDOEPHEDRINE HYDROCHLORIDE
RxCUI 91168
Orange Book
A209008
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": "21130-158_14aa89a7-5eb1-4037-a169-cbb527b46e95",
"productndc": "21130-158",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "209008",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "120MG",
"product_no": "001",
"approval_date": "Jun 9, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "PSEUDOEPHEDRINE HYDROCHLORIDE",
"proprietary_name": "Pseudoephedrine HCl",
"active_ingred_unit": "mg/1",
"application_number": "ANDA209008",
"marketing_category": "ANDA",
"nonproprietary_name": "Pseudoephedrine HCl",
"start_marketing_date": "20230901",
"active_numerator_strength": "120"
}Related drugs
Other records sharing ATC code R01BA52.
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