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United States · US · US:50090-6467_17cc096b-1c05-43c4-a4e7-68f633ca212a
Promethazine Hydrochloride and Dextromethorphan Hydrobromide
Orange BookUNIISPLATC R05DA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeR05DA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc115009064670473 mL in 1 BOTTLE, PLASTIC (50090-6467-0)
- ndc115009064671473 mL in 1 BOTTLE, PLASTIC (50090-6467-1)
Annotations
UNII (FDA Substance ID)
9D2RTI9KYH
DEXTROMETHORPHAN HYDROBROMIDE
RxCUI 102490
Orange Book
A088864
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": "50090-6467_17cc096b-1c05-43c4-a4e7-68f633ca212a",
"productndc": "50090-6467",
"dosage_form": "SYRUP",
"orange_book": {
"appl_no": "088864",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "15MG/5ML;6.25MG/5ML",
"product_no": "001",
"approval_date": "Jan 4, 1985"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE",
"proprietary_name": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide",
"active_ingred_unit": "mg/5mL; mg/5mL",
"application_number": "ANDA088864",
"marketing_category": "ANDA",
"nonproprietary_name": "promethazine hydrochloride and dextromethorphan hydrobromide",
"start_marketing_date": "19850104",
"active_numerator_strength": "15; 6.25"
}Related drugs
Other records sharing ATC code R05DA.
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