FDA.reportPublic FDA data

Abuse-Deterrent oxycodone hydrochloride 5 MG Oral Tablet [Roxybond]

RxCUI
1944543
RxNorm name
Abuse-Deterrent oxycodone hydrochloride 5 MG Oral Tablet [Roxybond]
Display name
ROXYBOND (Oral Pill)
Full name
Abuse-Deterrent oxycodone hydrochloride 5 MG Oral Tablet [Roxybond]
Term type
SBD
Status
Active
Strength
5 mg
Dose form
Abuse-Deterrent Tab
Route
Oral Pill
Updated
2026-10-30 15:32:53

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
102017
Active start
102017
Multiple ingredient
NO
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
oxycodone hydrochloride5 MG / 1 EACHoxycodoneoxycodone hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Tablet317541

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
oxycodone7804

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRRoxyBond 5 MG Oral Tablet1NAMES
RxNorm NameAbuse-Deterrent oxycodone hydrochloride 5 MG Oral Tablet [Roxybond]1NAMES
RxNorm SynonymRoxyBond 5 MG Oral Tablet1NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID72398542-8e0a-47b2-afeb-9ca5a1f150831CODES
RxCUI19445431CODES
MMSL_CODEBD23751CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
81140-101-1081140-101RoxyBond Oxycodone hydrochlorideProtega Pharmaceuticals IncNDA209777

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
NDA20977781140-101RoxyBond Oxycodone hydrochlorideNDAProtega Pharmaceuticals Inc

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 3 matching rows.

NDC11, Source, Active table
NDC11SourceActive
81140010110rxnav_ndcsyes
65597050110rxnav_historical
69296000501rxnav_historical

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RoxyBondOXYCODONE HYDROCHLORIDEProtega Pharmaceuticals Inc72398542-8e0a-47b2-afeb-9ca5a1f150832026-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 81140-101-10
ndc (product): 81140-101
ndc11 (package): 81140010110
rxcui: 1944543

Reported adverse events (FAERS/openFDA)#

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

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
72398542-8e0a-47b2-afeb-9ca5a1f15083RoxyBond 5 MG Oral Tablet [PSN] · Abuse-Deterrent oxycodone hydrochloride 5 MG Oral Tablet [Roxybond] [SBD] · RoxyBond 5 MG Oral Tablet [SY]311These highlights do not include all the information needed to use ROXYBOND™ safely and effectively. See full prescribing information for ROXYBOND. ROXYBOND (oxycodone hydrochloride) tablets, for oral use, CII Initial U.S. Approval: 195020260113

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
72398542-8e0a-47b2-afeb-9ca5a1f15083These highlights do not include all the information needed to use ROXYBOND™ safely and effectively. See full prescribing information for ROXYBOND. ROXYBOND (oxycodone hydrochloride) tablets, for oral use, CII Initial U.S. Approval: 1950Protega Pharmaceuticals Inc | Galephar Pharmaceutical Research Inc20260113
72398542-8e0a-47b2-afeb-9ca5a1f15083These highlights do not include all the information needed to use ROXYBOND™ safely and effectively. See full prescribing information for ROXYBOND. ROXYBOND (oxycodone hydrochloride) tablets, for oral use, CII Initial U.S. Approval: 1950Protega Pharmaceuticals Inc | Galephar Pharmaceutical Research Inc20251222
2d0eca5d-fe5f-410b-991e-5e365c173703These highlights do not include all the information needed to use ROXYBOND ™ safely and effectively. See full prescribing information for ROXYBOND . ROXYBOND ( oxycodone hydrochloride ) tablets , for oral use , CII Initial U.S. Approval: 1950Daiichi Sankyo Inc.20190528

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCN02AANatural opium alkaloidsATC1-4oxycodone
FDASPLN0000175690Opioid AgonistEPChas_epcoxycodone
FDASPLN0000175684Full Opioid AgonistsMOAhas_moaoxycodone
MEDRTD010098OxycodoneCHEMhas_ingredientoxycodone hydrochloride
MEDRTD010098OxycodoneCHEMhas_ingredientoxycodone
MEDRTD001249AsthmaDISEASEci_withoxycodone
MEDRTD001249AsthmaDISEASEci_withoxycodone hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withoxycodone
MEDRTD004342Drug HypersensitivityDISEASEci_withoxycodone hydrochloride
MEDRTD007415Intestinal ObstructionDISEASEci_withoxycodone
MEDRTD007415Intestinal ObstructionDISEASEci_withoxycodone hydrochloride
MEDRTD007418Intestinal Pseudo-ObstructionDISEASEci_withoxycodone hydrochloride
MEDRTD007418Intestinal Pseudo-ObstructionDISEASEci_withoxycodone
MEDRTD010149Postoperative PainDISEASEmay_treatoxycodone hydrochloride
MEDRTD010149Postoperative PainDISEASEmay_treatoxycodone
MEDRTD011247PregnancyDISEASEci_withoxycodone hydrochloride
MEDRTD011247PregnancyDISEASEci_withoxycodone
MEDRTD012131Respiratory InsufficiencyDISEASEci_withoxycodone hydrochloride
MEDRTD012131Respiratory InsufficiencyDISEASEci_withoxycodone
MEDRTN0000175684Full Opioid AgonistsMOAhas_moaoxycodone hydrochloride
MEDRTN0000175684Full Opioid AgonistsMOAhas_moaoxycodone
MEDRTN0000175439AnalgesiaPEhas_peoxycodone
MEDRTN0000175439AnalgesiaPEhas_peoxycodone hydrochloride
MEDRTN0000008635Decreased GI MotilityPEhas_peoxycodone
MEDRTN0000008635Decreased GI MotilityPEhas_peoxycodone hydrochloride
MEDRTN0000008701Decreased Medullary Respiratory DrivePEhas_peoxycodone hydrochloride
MEDRTN0000008701Decreased Medullary Respiratory DrivePEhas_peoxycodone
MEDRTN0000008768Decreased Organized Electrical ActivityPEhas_peoxycodone
MEDRTN0000008768Decreased Organized Electrical ActivityPEhas_peoxycodone hydrochloride
MEDRTN0000009353Increased Histamine ProductionPEhas_peoxycodone
MEDRTN0000009353Increased Histamine ProductionPEhas_peoxycodone hydrochloride

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH5 MG
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESQUALITATIVE_DISTINCTIONAbuse-Deterrent
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE2
CODESNDANDA209777
NAMESPrescribable SynonymRoxyBond 5 MG Oral Tablet
NAMESTallman SynonymAbuse-Deterrent oxyCODONE hydrochloride 5 MG Oral Tablet [Roxybond]
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon