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 16 of 24 · 474 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eye WashWATERHubei Changjian Medical Products Co., Ltd.d57e1c5b-1edc-4a94-88bc-f9ecf347b7ea2024-10-11WarningsExact identifier
unii: 059QF0KO0R
teruflex blood bag system with diversion blood sampling arm 70 ml cpda-1ANHYDROUS CITRIC ACID, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, DEXTROSE MONOHYDRATE, AND ADENINETerumo Corporation86b3a329-c83f-4977-92f5-0e9dfe1872d72024-10-10WarningsExact identifier
unii: XF417D3PSL
unii: B22547B95K
Bio Co-Enzyme PhaseCARDUUS MARIANUS, ASCORBICUM ACIDUM, CYSTEINUM, NATRUM OXALACETICUM, NICOTINAMIDUM, PULSATILLA (PRATENSIS), PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, ALPHA-KETOGLUTARICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CERIUM OXALICUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MAGNESIUM OROTICUM DIHYDRICUM, MALICUM ACIDUM, NADIDUM, NATRUM PYRUVICUM, PANTOTHENIC ACID, SUCCINICUM ACIDUM, ADRENALINUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, HEPAR SULPHURIS CALCAREUM, SULPHUR, ACONITICUM ACIDUM, CIS-,Deseret Biologicals, Inc.afad858e-064f-454d-be78-da1501ffe8532024-10-04WarningsExact identifier
unii: XF417D3PSL
TERUFLEX BLOOD with Diversion Blood Sampling Arm 70 mL CPDA-1ANHYDROUS CITRIC ACID, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, DEXTROSE MONOHYDRATE, AND ADENINETerumo Corporation39f2e11c-5a31-469f-b725-d096c16744212024-10-03WarningsExact identifier
unii: XF417D3PSL
unii: B22547B95K
SODIUM PHENYLACETATE AND SODIUM BENZOATESODIUM PHENYLACETATE AND SODIUM BENZOATEZydus Pharmaceuticals USA Inc.204e84a7-5440-4537-9e40-06eb56c415e92024-09-30Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
Sodium Phenylacetate and sodium benzoateSODIUM PHENYLACETATE AND SODIUM BENZOATENavinta LLCfbc7bfe3-6faa-45a3-befb-9ad7963c05712024-09-30Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
TERUFLEX Blood Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) for Collection of 450mL of BloodANHYDROUS CITRIC ACID, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, DEXTROSE MONOHYDRATE, AND ADENINETerumo Corporation02015040-9b71-4dbe-8f8d-e0d0951e8f932024-09-19WarningsExact identifier
unii: XF417D3PSL
unii: B22547B95K
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENNuCare Pharmaceuticals,Inc.223fe2b4-aa12-81fd-e063-6394a90a6c082024-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDELupin Pharmaceuticals, Inc.3eddd18b-695a-4e53-a76c-f6779515b9182024-09-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1049615
unii: C1ENJ2TE6C
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDENuCare Pharmaceuticals,Inc.ef58f422-682e-6896-e053-2a95a90a1f2d2024-09-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
ENDOCETOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack7dc10b86-c6cd-4012-b7b9-b694ccf4f7682024-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEBryant Ranch Prepack1bcddbe1-c453-43ec-a822-9e993b885a5f2024-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Quality Choice Effervescent Antacid and Pain Relief - Extra StrengthASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATEChain Drug Marketing Association1f926637-a61c-8eb7-e063-6394a90a65022024-08-13WarningsExact identifier
unii: XF417D3PSL
EmpathyAETHUSA CYNAPIUM, AMBRA GRISEA, ARGEMONE MEXICANA, CANDIDA ALBICANS, CARLSBAD AQUA, CEREBRUM SUIS, COCCULUS INDICUS, COFFEA TOSTA, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, MAGNESIA CARBONICA, NATRUM CARBONICUM, NUPHAR LUTEUM, NUX MOSCHATA, PHOSPHORUS, PLACENTA TOTALIS SUIS, ROSA DAMASCENA, SUCCINUM, VIOLA ODORATADeseret Biologicals, Inc.a89067c1-ef12-49da-8fa6-e65ff664f4972024-08-13WarningsExact identifier
unii: 059QF0KO0R
ENDOCETOXYCODONE AND ACETAMINOPHENBryant Ranch Prepackf11f356e-967d-4099-9d87-5497790b397c2024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEBryant Ranch Prepack261132f9-ab96-4901-a660-a80c3e0f9d862024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENBryant Ranch Prepackc12c26be-ba05-4d25-a2bf-f87623c6ae572024-08-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
ENDOCETOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack3b8ef94a-da42-46b5-9fa9-2fac9ed6e7c32024-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEAmerican Health Packaging58fa9952-c8ab-4ebb-a073-15cc45f4832a2024-07-16Adverse reactionsExact identifier
unii: XF417D3PSL
Thompson Safety EyewashWATERThompson Safety1d0e96cf-245b-cfb7-e063-6294a90a4ced2024-07-12WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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