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United States · US · US:71205-654_68a4c521-6db0-4e94-9906-96e96e251301
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution
Orange BookUNIISPLATC R05DA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeR05DA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc117120565404118 mL in 1 BOTTLE (71205-654-04)
Annotations
UNII (FDA Substance ID)
9D2RTI9KYH
DEXTROMETHORPHAN HYDROBROMIDE
RxCUI 102490
Orange Book
A040649
AA
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": {
"b0ba50da-9f70-4531-a9de-3dd3f8aa1f5d": {
"match": "brand_token",
"title": "PROMETHAZINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]",
"spl_version": "19",
"published_date": "2026-05-25"
}
},
"productid": "71205-654_68a4c521-6db0-4e94-9906-96e96e251301",
"productndc": "71205-654",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "040649",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AA",
"strength": "15MG/5ML;6.25MG/5ML",
"product_no": "001",
"approval_date": "Feb 14, 2006"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE",
"proprietary_name": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution",
"active_ingred_unit": "mg/5mL; mg/5mL",
"application_number": "ANDA040649",
"marketing_category": "ANDA",
"nonproprietary_name": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution",
"start_marketing_date": "20201005",
"active_numerator_strength": "15; 6.25"
}Related drugs
Other records sharing ATC code R05DA.
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