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United States · US · US:17856-0065_36c12aae-7566-5b2d-e063-6294a90a0dd1
Promethazine Hydrochloride and Codeine Phosphate
Orange BookUNIISPLATC R05DA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerATLANTIC BIOLOGICALS CORP.
CountryUS (United States)
ATC codeR05DA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11178560065172 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0065-1) / 5 mL in 1 CUP, UNIT-DOSE
- ndc1117856006521 CUP, UNIT-DOSE in 1 BAG (17856-0065-2) / 5 mL in 1 CUP, UNIT-DOSE
Annotations
UNII (FDA Substance ID)
GSL05Y1MN6
CODEINE PHOSPHATE
RxCUI 2672
Orange Book
A200386
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": "17856-0065_36c12aae-7566-5b2d-e063-6294a90a0dd1",
"productndc": "17856-0065",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "200386",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AA",
"strength": "10MG/5ML;6.25MG/5ML",
"product_no": "001",
"approval_date": "Jun 29, 2012"
}
],
"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": "ANDA200386",
"marketing_category": "ANDA",
"nonproprietary_name": "Promethazine Hydrochloride and Codeine Phosphate",
"start_marketing_date": "20180312",
"active_numerator_strength": "10; 6.25"
}Related drugs
Other records sharing ATC code R05DA.
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