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United States · US · US:0121-1070_acf1463f-bbbe-42e9-9b06-a306e95a4325
Promethazine DM
Orange BookUNIISPLATC R05DA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPAI Holdings, LLC dba PAI Pharma
CountryUS (United States)
ATC codeR05DA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc110121107004118 mL in 1 BOTTLE (0121-1070-04)
- ndc110121107016473 mL in 1 BOTTLE (0121-1070-16)
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": "0121-1070_acf1463f-bbbe-42e9-9b06-a306e95a4325",
"productndc": "0121-1070",
"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 DM",
"active_ingred_unit": "mg/5mL; mg/5mL",
"application_number": "ANDA040649",
"marketing_category": "ANDA",
"nonproprietary_name": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide",
"start_marketing_date": "20250604",
"active_numerator_strength": "15; 6.25"
}Related drugs
Other records sharing ATC code R05DA.
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