FDA.reportPublic FDA data

NDC 64950-353-01 - Oxycodone Hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
64950-353
Requested NDC
64950-353-01
Package NDCs from labels
64950-353-03, 64950-353-01, 64950-353-91, 64950-353-51, 64950-353-02, 64950-353-92, 64950-353-52
Manufacturer
Genus Lifesciences Inc.
Effective date
2026-04-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Oxycodone Hydrochloride - Genus Lifesciences Inc.Genus Lifesciences Inc.2026-04-16HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64950-353-01Oxycodone Hydrochloride0.5 mL in 1 SYRINGE, PLASTICSOLUTION0.525
64950-353-02Oxycodone Hydrochloride1 mL in 1 SYRINGE, PLASTICSOLUTION125
64950-353-03Oxycodone Hydrochloride1 in 1 CARTONSOLUTION125
64950-353-03Oxycodone Hydrochloride30 mL in 1 BOTTLE, PLASTICSOLUTION3025
64950-353-51Oxycodone Hydrochloride50 in 1 CASESOLUTION5025
64950-353-52Oxycodone Hydrochloride50 in 1 CASESOLUTION5025
64950-353-91Oxycodone Hydrochloride5 in 1 POUCHSOLUTION525
64950-353-92Oxycodone Hydrochloride5 in 1 POUCHSOLUTION525

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64950-353OXYCODONE HYDROCHLORIDE SOLUTION [GENUS LIFESCIENCES INC.]23Legacy NDC, 8 package rows20240927_6869fec9-1837-4221-afd8-5cc6fadd025d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Oxycodone HydrochlorideACTIVE INGREDIENTC1ENJ2TE6COXYCODONE HYDROCHLORIDE SOLUTION [LEHIGH VALLEY TECHNOLOGIES, INC.]11
OxycodoneACTIVE MOIETYCD35PMG570OXYCODONE HYDROCHLORIDE SOLUTION [LEHIGH VALLEY TECHNOLOGIES, INC.]11
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLOXYCODONE HYDROCHLORIDE SOLUTION [LEHIGH VALLEY TECHNOLOGIES, INC.]11
D&C Yellow no. 10INACTIVE INGREDIENT35SW5USQ3GOXYCODONE HYDROCHLORIDE SOLUTION [LEHIGH VALLEY TECHNOLOGIES, INC.]11
FD&C Red no. 40INACTIVE INGREDIENTWZB9127XOAOXYCODONE HYDROCHLORIDE SOLUTION [LEHIGH VALLEY TECHNOLOGIES, INC.]11
saccharin sodiumINACTIVE INGREDIENTSB8ZUX40TYOXYCODONE HYDROCHLORIDE SOLUTION [LEHIGH VALLEY TECHNOLOGIES, INC.]11
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUOXYCODONE HYDROCHLORIDE SOLUTION [LEHIGH VALLEY TECHNOLOGIES, INC.]11
sorbitolINACTIVE INGREDIENT506T60A25ROXYCODONE HYDROCHLORIDE SOLUTION [LEHIGH VALLEY TECHNOLOGIES, INC.]11
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KOXYCODONE HYDROCHLORIDE SOLUTION [LEHIGH VALLEY TECHNOLOGIES, INC.]11
waterINACTIVE INGREDIENT059QF0KO0ROXYCODONE HYDROCHLORIDE SOLUTION [LEHIGH VALLEY TECHNOLOGIES, INC.]11

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 7 of 24 · 474 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEMAJOR PHARMACEUTICALS6d249bc5-79c4-4c42-a71b-d667c75163db2026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1049604
unii: C1ENJ2TE6C
RoxyBondOXYCODONE HYDROCHLORIDEProtega Pharmaceuticals Inc72398542-8e0a-47b2-afeb-9ca5a1f150832026-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENKVK-Tech, Inc.9986aa04-c976-4654-8ad7-b97d2eecea932026-01-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEStrides Pharma Science Limitedf3116ebf-d72c-4e98-aa50-006be4770c862026-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
unii: 059QF0KO0R
Cell Energy Performance Drops 2048CELL ENERGY PERFORMANCE DROPSProfessional Complementary Health Formulas8701ea61-5d5f-466b-8d2c-f808e7b4d8fe2026-01-08WarningsExact identifier
unii: XF417D3PSL
Metab 6012METABProfessional Complementary Health Formulasf3576d6f-c9ab-4370-8a32-b6c4bf6ba4fd2026-01-08WarningsExact identifier
unii: XF417D3PSL
Herbal Diuretic Liquescence 3011HERBAL DIURETIC LIQUESCENCEProfessional Complementary Health Formulas5eee7f21-a3c4-46e0-a642-a4ca635734e32026-01-08WarningsExact identifier
unii: XF417D3PSL
OXAYDOOXYCODONE HYDROCHLORIDEZyla Life Sciences US LLCcff0c64a-63f5-4b3c-909a-cdecf6755cbe2026-01-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Oxycodone hydrochlorideOXYCODONE HYDROCHLORIDEAlvogen, Inc.20bb6bb4-230a-c9c2-01d8-a6e9341e96ba2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Eye CleanEYE WASHHART Health41f53e2e-c2bc-4bf1-a541-3bcb2cf630022025-12-31WarningsExact identifier
unii: 059QF0KO0R
GeriCare Sorbitol SolutionSORBITOLGERI-CARE PHARMACEUTICALS, CORPb4dd7a41-380e-d94b-e053-2a95a90ac34a2025-12-31WarningsExact identifier
unii: 506T60A25R
teeth and gumsCALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOSSiddha Flower Essences LLC926c79d5-d270-4c0d-aca9-b58571c24f3a2025-12-31WarningsExact identifier
unii: 059QF0KO0R
lung and sinusCALC PHOS, FERRUM PHOS, GENTIANELLA AMARELLA, FLOS, KALI MUR, KALI PHOS, KALI SULPH, ROCK WATER, ROSE CANINA, FLOSSiddha Flower Essences LLC9f7c949f-21bc-473c-ab8d-24837893fccc2025-12-31WarningsExact identifier
unii: 059QF0KO0R
Quality Choice Eye WashWATERChain Drug Marketing Assoc., Inc.1fb8a109-351b-7039-e063-6394a90a73112025-12-30WarningsExact identifier
unii: 059QF0KO0R
Rite Aid Eye WashPURIFIED WATERRite Aid28a18e04-d735-a511-e063-6394a90af6bb2025-12-30WarningsExact identifier
unii: 059QF0KO0R
OCUFRESHWATEROptics Laboratory Inc.b8e477a9-66b9-496b-92fb-3d4bbd7b36b52025-12-29WarningsExact identifier
unii: 059QF0KO0R
Kollourion Eyesalve EyewashPURIFIED WATER 98.3%Miracle Eye Pharmaceuticalsb56d2ab9-169b-b490-e053-2a95a90a80b32025-12-28WarningsExact identifier
unii: 059QF0KO0R
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEAsclemed USA, Inc.056bdaac-4a43-42f0-9435-f349d3ccc1282025-12-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.