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United States · US · US:65162-039_bdfe8cad-61bb-48eb-a5c4-ec21abde055a
Guaifenesin and Dextromethorphan HBr
Orange BookUNIISPLATC R05DA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeR05DA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1165162039031 BOTTLE in 1 CARTON (65162-039-03) / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE
- ndc1165162039061 BOTTLE in 1 CARTON (65162-039-06) / 60 TABLET, EXTENDED RELEASE in 1 BOTTLE
- ndc1165162039172 BLISTER PACK in 1 CARTON (65162-039-17) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
9D2RTI9KYH
DEXTROMETHORPHAN HYDROBROMIDE
RxCUI 102490
Orange Book
A209692
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": {
"9cfb1abb-98c4-4e90-8dd7-fcffc112f988": {
"match": "brand_token",
"title": "GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [CARDINAL HEALTH 107, LLC]",
"spl_version": "8",
"published_date": "2026-05-21"
}
},
"productid": "65162-039_bdfe8cad-61bb-48eb-a5c4-ec21abde055a",
"productndc": "65162-039",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "209692",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "30MG;600MG",
"product_no": "001",
"approval_date": "Nov 1, 2018"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "60MG;1.2GM",
"product_no": "002",
"approval_date": "Nov 1, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
"proprietary_name": "Guaifenesin and Dextromethorphan HBr",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA209692",
"marketing_category": "ANDA",
"nonproprietary_name": "Guaifenesin and Dextromethorphan HBr",
"start_marketing_date": "20181101",
"active_numerator_strength": "60; 1200"
}Related drugs
Other records sharing ATC code R05DA.
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