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United States · US · US:65162-694_fa597180-cb04-48de-ba6c-1cc3781d7f31
Promethazine and Phenylephrine HCl, and Codeine Phosphate
Orange BookUNIISPLATC R05DA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeR05DA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116516269486118 mL in 1 BOTTLE (65162-694-86)
- ndc116516269490473 mL in 1 BOTTLE (65162-694-90)
Annotations
UNII (FDA Substance ID)
GSL05Y1MN6
CODEINE PHOSPHATE
RxCUI 2672
Orange Book
A200963
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": "65162-694_fa597180-cb04-48de-ba6c-1cc3781d7f31",
"productndc": "65162-694",
"dosage_form": "SYRUP",
"orange_book": {
"appl_no": "200963",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "10MG/5ML;5MG/5ML;6.25MG/5ML",
"product_no": "001",
"approval_date": "Aug 26, 2015"
}
],
"appl_type": "A"
},
"dea_schedule": "CV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE",
"proprietary_name": "Promethazine and Phenylephrine HCl, and Codeine Phosphate",
"active_ingred_unit": "mg/5mL; mg/5mL; mg/5mL",
"application_number": "ANDA200963",
"marketing_category": "ANDA",
"nonproprietary_name": "Promethazine, Phenylephrine, Codeine",
"start_marketing_date": "20131101",
"active_numerator_strength": "10; 5; 6.25"
}Related drugs
Other records sharing ATC code R05DA.
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