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United States · US · US:64597-301_545d121c-01b2-4375-9067-52fc8ad23d74
NUEDEXTA
Orange BookUNIISPLATC R05DA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAvanir Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeR05DA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1164597301131 BOTTLE in 1 CARTON (64597-301-13) / 13 CAPSULE, GELATIN COATED in 1 BOTTLE
- ndc11645973016060 CAPSULE, GELATIN COATED in 1 BOTTLE (64597-301-60)
Annotations
UNII (FDA Substance ID)
9D2RTI9KYH
DEXTROMETHORPHAN HYDROBROMIDE
RxCUI 102490
Orange Book
N021879
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "9D2RTI9KYH",
"rxcui": "102490",
"inchikey": "STTADZBLEUMJRG-IKNOHUQMSA-N",
"display_name": "DEXTROMETHORPHAN HYDROBROMIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"c8cce784-8c5f-415b-8068-76e5d481d159": {
"match": "brand_token",
"title": "NUEDEXTA (DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE) CAPSULE, GELATIN COATED [OTSUKA AMERICA PHARMACEUTICAL, INC]",
"spl_version": "4",
"published_date": "2026-01-26"
}
},
"productid": "64597-301_545d121c-01b2-4375-9067-52fc8ad23d74",
"productndc": "64597-301",
"dosage_form": "CAPSULE, GELATIN COATED",
"orange_book": {
"appl_no": "021879",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "20MG;10MG",
"product_no": "001",
"approval_date": "Oct 29, 2010"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE",
"proprietary_name": "NUEDEXTA",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "NDA021879",
"marketing_category": "NDA",
"nonproprietary_name": "dextromethorphan hydrobromide and quinidine sulfate",
"start_marketing_date": "20101201",
"active_numerator_strength": "20; 10"
}Related drugs
Other records sharing ATC code R05DA.
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