FDA.reportPublic FDA data

Abuse-Deterrent 12 HR oxycodone hydrochloride 10 MG Extended Release Oral Tablet [Oxycontin]

RxCUI
1049504
RxNorm name
Abuse-Deterrent 12 HR oxycodone hydrochloride 10 MG Extended Release Oral Tablet [Oxycontin]
Display name
OxyCONTIN XR (Oral Pill)
Full name
Abuse-Deterrent 12 HR oxycodone hydrochloride 10 MG Extended Release Oral Tablet [Oxycontin]
Term type
SBD
Status
Active
Strength
10 mg
Dose form
Abuse-Deterrent 12 HR XR Tab
Route
Oral Pill
Updated
2026-10-20 20:47:14

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
012011
Active start
012011
Multiple ingredient
NO
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
oxycodone hydrochloride10 MG / 1 EACHoxycodoneoxycodone hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Extended Release Oral Tablet316945

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
oxycodone7804

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STR12 HR OxyCONTIN 10 MG Extended Release Oral Tablet1NAMES
RxNorm NameAbuse-Deterrent 12 HR oxycodone hydrochloride 10 MG Extended Release Oral Tablet [Oxycontin]1NAMES
RxNorm Synonym
2 linked values
2NAMES
TTYSBD1ATTRIBUTES
SPL_SET_IDbfdfe235-d717-4855-a3c8-a13d26dadede1CODES
RxCUI10495041CODES
MMSL_CODEBD53171CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
59011-410-1059011-410OxyContin oxycodone hydrochlorideKnoa Pharma LLCNDA022272
59011-410-2059011-410OxyContin oxycodone hydrochlorideKnoa Pharma LLCNDA022272

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
NDA02227259011-410OxyContin oxycodone hydrochlorideNDAKnoa Pharma LLC

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 80 matching rows.

NDC11, Source, Active table
NDC11SourceActive
59011041010rxnav_ndcsyes
59011041020rxnav_ndcsyes
10544059120rxnav_historical
10544059130rxnav_historical
16590067710rxnav_historical
16590067715rxnav_historical
16590067720rxnav_historical
16590067730rxnav_historical
16590067760rxnav_historical
16590067762rxnav_historical
16590067772rxnav_historical
16590067790rxnav_historical
35356009010rxnav_historical
35356009014rxnav_historical
35356009030rxnav_historical
35356078510rxnav_historical
35356078514rxnav_historical
35356078530rxnav_historical
35356078560rxnav_historical
35356078590rxnav_historical
43063035402rxnav_historical
43063035410rxnav_historical
48692003010rxnav_historical
48692003020rxnav_historical
48692003025rxnav_historical
48692060010rxnav_historical
48692060025rxnav_historical
48692060030rxnav_historical
48692061010rxnav_historical
48692061030rxnav_historical
48692062010rxnav_historical
48692062012rxnav_historical
48692062030rxnav_historical
48692069030rxnav_historical
48692088010rxnav_historical
48692088025rxnav_historical
54868381300rxnav_historical
54868381301rxnav_historical
54868381302rxnav_historical
54868381303rxnav_historical
54868381304rxnav_historical
54868381305rxnav_historical
59011010010rxnav_historical
59011010020rxnav_historical
59011010025rxnav_historical
63629377501rxnav_historical
63629377502rxnav_historical
63629377503rxnav_historical
63629377504rxnav_historical
63629377505rxnav_historical
63629386101rxnav_historical
63629386102rxnav_historical
63629386103rxnav_historical
63629386104rxnav_historical
63629386105rxnav_historical
63629386106rxnav_historical
63629386107rxnav_historical
65505002010rxnav_historical
65505003001rxnav_historical
65505003010rxnav_historical
65505003025rxnav_historical
65505010010rxnav_historical
65505022010rxnav_historical
65505044110rxnav_historical
65505044130rxnav_historical
65505060012rxnav_historical
65505060030rxnav_historical
65505062010rxnav_historical
65505062012rxnav_historical
65505062030rxnav_historical
65505064330rxnav_historical
65505066010rxnav_historical
65505066030rxnav_historical
65505070010rxnav_historical
65505070030rxnav_historical
65505082010rxnav_historical
66336093630rxnav_historical
68071044790rxnav_historical
68071073830rxnav_historical
68071073860rxnav_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
OxyContinOXYCODONE HYDROCHLORIDEKnoa Pharma LLCbfdfe235-d717-4855-a3c8-a13d26dadede2026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 59011-410-10
ndc (package): 59011-410-20
ndc (product): 59011-410
ndc11 (package): 59011041020
ndc11 (package): 59011041010
rxcui: 1049504

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
bfdfe235-d717-4855-a3c8-a13d26dadedeOxyCONTIN 10 MG 12HR Extended Release Oral Tablet [PSN] · Abuse-Deterrent 12 HR oxycodone hydrochloride 10 MG Extended Release Oral Tablet [Oxycontin] [SBD] · 12 HR Oxycontin 10 MG Extended Release Oral Tablet [SY] · OxyContin 10 MG 12 HR Extended Release Oral Tablet [SY]443These highlights do not include all the information needed to use OXYCONTIN ® safely and effectively. See full prescribing information for OXYCONTIN. OXYCONTIN ® (oxycodone hydrochloride) extended-release tablets, for oral use, CII Initial U.S. Approval: 195020260501

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
bfdfe235-d717-4855-a3c8-a13d26dadedeThese highlights do not include all the information needed to use OXYCONTIN ® safely and effectively. See full prescribing information for OXYCONTIN. OXYCONTIN ® (oxycodone hydrochloride) extended-release tablets, for oral use, CII Initial U.S. Approval: 1950Knoa Pharma LLC | Knoa Pharmaceuticals L.P. | AndersonBrecon Inc. | Noramco | Aphena Pharma Solutions | Sharp Packaging Services, LLC20260624
bfdfe235-d717-4855-a3c8-a13d26dadedeThese highlights do not include all the information needed to use OXYCONTIN ® safely and effectively. See full prescribing information for OXYCONTIN. OXYCONTIN ® (oxycodone hydrochloride) extended-release tablets, for oral use, CII Initial U.S. Approval: 1950Knoa Pharma LLC | Knoa Pharmaceuticals L.P. | AndersonBrecon Inc. | Noramco | Aphena Pharma Solutions | Sharp Packaging Services, LLC20260501
bfdfe235-d717-4855-a3c8-a13d26dadedeThese highlights do not include all the information needed to use OXYCONTIN ® safely and effectively. See full prescribing information for OXYCONTIN. OXYCONTIN ® (oxycodone hydrochloride) extended-release tablets, for oral use, CII Initial U.S. Approval: 1950Knoa Pharma LLC | Knoa Pharmaceuticals L.P. | AndersonBrecon Inc. | Noramco | Aphena Pharma Solutions | Sharp Packaging Services, LLC20260326
bfdfe235-d717-4855-a3c8-a13d26dadedeThese highlights do not include all the information needed to use OXYCONTIN ® safely and effectively. See full prescribing information for OXYCONTIN. OXYCONTIN ® (oxycodone hydrochloride) extended-release tablets, for oral use, CII Initial U.S. Approval: 1950Purdue Pharma LP | Purdue Pharmaceuticals L.P. | AndersonBrecon Inc. | Noramco | Aphena Pharma Solutions | Sharp Packaging Services, LLC20260130
bfdfe235-d717-4855-a3c8-a13d26dadedeThese highlights do not include all the information needed to use OXYCONTIN ® safely and effectively. See full prescribing information for OXYCONTIN. OXYCONTIN ® (oxycodone hydrochloride) extended-release tablets, for oral use, CII Initial U.S. Approval: 1950Purdue Pharma LP | Purdue Pharmaceuticals L.P. | AndersonBrecon Inc. | Noramco | Aphena Pharma Solutions | Sharp Packaging Services, LLC20251231
8cd841f7-9420-417f-9814-04dcb9b48737These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS CII Initial U.S. Approval: 1950Bryant Ranch Prepack20211222
a393ac2f-b9b4-4e82-8a69-93879d246319National Council for Prescription Drug Programs20130219
a6cbffda-c51a-43e9-93a5-f1a037e1b60cNational Council for Prescription Drug Programs20130219
b5782954-0940-4f30-8173-ceb19bc1cfc7National Council for Prescription Drug Programs20130219
b8a57c06-6131-4a6a-a68a-125a63a6109dNational Council for Prescription Drug Programs20130219
c26aef03-404d-4c70-aff0-e2b3ee24fc19National Council for Prescription Drug Programs20130213
d17534dd-5a21-4cb7-88b5-2ecc20dcd38dNational Council for Prescription Drug Programs20120724
0f6098f2-c7c3-41e0-ba5d-2a4463c68a35National Council for Prescription Drug Programs20120724
d119f33f-a042-4415-8ce1-6483228c4594National Council for Prescription Drug Programs20120724
ceaf34a4-de24-4292-a3ce-fd8752664c03National Council for Prescription Drug Programs20120724
c53c7e85-b5d4-4dae-9718-288e2a726692National Council for Prescription Drug Programs20120724
939e8ca9-5bd3-45a2-a6f5-9d34b1de728fNational Council for Prescription Drug Programs20120724
63ce1ccf-44d4-461e-ae69-3a79bca58b35National Council for Prescription Drug Programs20120724
1b0fc76e-485a-4780-b38e-86041722a1e2National Council for Prescription Drug Programs20120724

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_STRENGTH10 MG
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESQUALITATIVE_DISTINCTIONAbuse-Deterrent
ATTRIBUTESQUANTITY12 HR
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE2
CODESNDANDA022272
NAMESPrescribable SynonymOxyCONTIN 10 MG 12HR Extended Release Oral Tablet
NAMESTallman Synonym12 HR OxyCONTIN 10 MG Extended Release Oral Tablet
NAMESTallman SynonymAbuse-Deterrent 12 HR oxyCODONE hydrochloride 10 MG Extended Release Oral Tablet [OxyCONTIN]
NAMESTallman SynonymOxyCONTIN 10 MG 12 HR Extended Release Oral Tablet
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon