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United States · US · US:31722-693_2d3a1851-0309-c3a1-e063-6294a90abd14
Dextromethorphan hydrobromide and quinidine sulfate
Orange BookUNIISPLATC R05DA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCamber Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeR05DA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11317226936060 CAPSULE in 1 BOTTLE (31722-693-60)
Annotations
UNII (FDA Substance ID)
9D2RTI9KYH
DEXTROMETHORPHAN HYDROBROMIDE
RxCUI 102490
Orange Book
A218426
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": {
"4fde00af-3824-44f1-8a5f-d88518e0a8c8": {
"match": "brand_token",
"title": "DEXTROMETHORPHAN POLISTIREX SUSPENSION, EXTENDED RELEASE [AUROHEALTH LLC]",
"spl_version": "2",
"published_date": "2026-05-20"
}
},
"productid": "31722-693_2d3a1851-0309-c3a1-e063-6294a90abd14",
"productndc": "31722-693",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "218426",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG;10MG",
"product_no": "001",
"approval_date": "Aug 28, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE",
"proprietary_name": "Dextromethorphan hydrobromide and quinidine sulfate",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA218426",
"marketing_category": "ANDA",
"nonproprietary_name": "Dextromethorphan hydrobromide and quinidine sulfate",
"start_marketing_date": "20240828",
"active_numerator_strength": "20; 10"
}Related drugs
Other records sharing ATC code R05DA.
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