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United States · US · US:70752-139_ea7f15a6-079d-4146-a13d-74c129ec598e
Promethazine Hydrochloride and Codeine Phosphate
Orange BookUNIISPLATC R05DA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerQUAGEN PHARMACEUTICALS LLC
CountryUS (United States)
ATC codeR05DA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc117075213906118 mL in 1 BOTTLE, PLASTIC (70752-139-06)
- ndc117075213912473 mL in 1 BOTTLE, PLASTIC (70752-139-12)
Annotations
UNII (FDA Substance ID)
GSL05Y1MN6
CODEINE PHOSPHATE
RxCUI 2672
Orange Book
A214238
AA
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "GSL05Y1MN6",
"rxcui": "2672",
"inchikey": "DKSZLDSPXIWGFO-BLOJGBSASA-N",
"display_name": "CODEINE PHOSPHATE",
"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": "70752-139_ea7f15a6-079d-4146-a13d-74c129ec598e",
"productndc": "70752-139",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "214238",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "10MG/5ML;6.25MG/5ML",
"product_no": "001",
"approval_date": "Oct 8, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": "CV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE",
"proprietary_name": "Promethazine Hydrochloride and Codeine Phosphate",
"active_ingred_unit": "mg/5mL; mg/5mL",
"application_number": "ANDA214238",
"marketing_category": "ANDA",
"nonproprietary_name": "Promethazine Hydrochloride and Codeine Phosphate",
"start_marketing_date": "20201008",
"active_numerator_strength": "10; 6.25"
}Related drugs
Other records sharing ATC code R05DA.
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