🇺🇸
United States · US · US:65162-799_9eb36122-c3bf-4b04-84a1-bb137f884c40
Dextromethorphan Polistirex Extended-Release
Orange BookUNIISPLATC N07XX59
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeN07XX59
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1165162799761 BOTTLE in 1 CARTON (65162-799-76) / 89 mL in 1 BOTTLE
- ndc1165162799771 BOTTLE in 1 CARTON (65162-799-77) / 148 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
9D2RTI9KYH
DEXTROMETHORPHAN HYDROBROMIDE
RxCUI 102490
Orange Book
A203133
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": "65162-799_9eb36122-c3bf-4b04-84a1-bb137f884c40",
"productndc": "65162-799",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "203133",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 30MG HYDROBROMIDE/5ML",
"product_no": "001",
"approval_date": "Jul 28, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "DEXTROMETHORPHAN HYDROBROMIDE",
"proprietary_name": "Dextromethorphan Polistirex Extended-Release",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA203133",
"marketing_category": "ANDA",
"nonproprietary_name": "Dextromethorphan Polistirex",
"start_marketing_date": "20170801",
"active_numerator_strength": "30"
}Related drugs
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