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United States · US · US:27808-057_c48beb7d-69be-4ace-82b1-d1a1210b7f32
Promethazine Hydrochloride and Dextromethorphan Hydrobromide
Orange BookUNIISPLATC R05DA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCranbury Pharmaceuticals, LLC
CountryUS (United States)
ATC codeR05DA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc112780805701473 mL in 1 BOTTLE, PLASTIC (27808-057-01)
Annotations
UNII (FDA Substance ID)
9D2RTI9KYH
DEXTROMETHORPHAN HYDROBROMIDE
RxCUI 102490
Orange Book
A091687
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": "27808-057_c48beb7d-69be-4ace-82b1-d1a1210b7f32",
"productndc": "27808-057",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "091687",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "15MG/5ML;6.25MG/5ML",
"product_no": "001",
"approval_date": "Jun 28, 2012"
}
],
"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": "ANDA091687",
"marketing_category": "ANDA",
"nonproprietary_name": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide",
"start_marketing_date": "20140131",
"active_numerator_strength": "15; 6.25"
}Related drugs
Other records sharing ATC code R05DA.
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