FDA.reportPublic FDA data

oxycodone hydrochloride 5 MG Oral Capsule

RxCUI
1049696
RxNorm name
oxycodone hydrochloride 5 MG Oral Capsule
Display name
oxyCODONE (Oral Pill)
Full name
oxycodone hydrochloride 5 MG Oral Capsule
Term type
SCD
Status
Active
Strength
5 mg
Dose form
Cap
Route
Oral Pill
Updated
2026-10-20 20:47:29

RxNorm Status History#

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

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 Capsule316965

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
oxycodone7804

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRoxyCODONE hydrochloride 5 MG Oral Capsule1NAMES
RxNorm Nameoxycodone hydrochloride 5 MG Oral Capsule1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID
3 linked values
3CODES
RxCUI10496961CODES
MMSL_CODE
2 linked values
2CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
10702-023-0110702-023Oxycodone Hydrochloride Oxycodone HydrochlorideKVK-TECH, INC.ANDA202773
10702-023-0610702-023Oxycodone Hydrochloride Oxycodone HydrochlorideKVK-TECH, INC.ANDA202773
40032-950-0140032-950Oxycodone Hydrochloride Oxycodone HydrochlorideNovel Laboratories, Inc.ANDA204752
40032-950-0340032-950Oxycodone Hydrochloride Oxycodone HydrochlorideNovel Laboratories, Inc.ANDA204752
40032-950-5040032-950Oxycodone Hydrochloride Oxycodone HydrochlorideNovel Laboratories, Inc.ANDA204752
62559-167-0162559-167Oxycodone Hydrochloride Oxycodone HydrochlorideANI Pharmaceuticals, Inc.ANDA205177

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA20277310702-023Oxycodone Hydrochloride Oxycodone HydrochlorideANDAKVK-TECH, INC.
ANDA20475240032-950Oxycodone Hydrochloride Oxycodone HydrochlorideANDANovel Laboratories, Inc.
ANDA20517762559-167Oxycodone Hydrochloride Oxycodone HydrochlorideANDAANI Pharmaceuticals, Inc.

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 51 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00527177401rxnav_ndcsyes
10702002301rxnav_ndcsyes
10702002306rxnav_ndcsyes
40032095001rxnav_ndcsyes
40032095003rxnav_ndcsyes
40032095050rxnav_ndcsyes
43386095001rxnav_ndcsyes
60687011611rxnav_ndcsyes
60687011621rxnav_ndcsyes
62559016701rxnav_ndcsyes
68308014501rxnav_ndcsyes
00406055401rxnav_historical
00406055462rxnav_historical
00756029200rxnav_historical
00756029201rxnav_historical
10609140701rxnav_historical_indirect
10609140709rxnav_historical_indirect
16590068456rxnav_historical_indirect
16590068460rxnav_historical_indirect
16590068472rxnav_historical_indirect
16590085430rxnav_historical
16590085456rxnav_historical
16590085460rxnav_historical
16590085472rxnav_historical
42549061056rxnav_historical
48692000610rxnav_historical_indirect
52152018702rxnav_historical
54868393200rxnav_historical
54868393201rxnav_historical
54868393202rxnav_historical
54868393203rxnav_historical
54868393204rxnav_historical
54868393205rxnav_historical
54868570000rxnav_historical
54868570001rxnav_historical
58177004104rxnav_historical
58177004111rxnav_historical
59011020110rxnav_historical_indirect
63629376301rxnav_historical
63629376302rxnav_historical
63629376303rxnav_historical
63629415501rxnav_historical
63629415502rxnav_historical
63629415503rxnav_historical
63629415504rxnav_historical
64950020401rxnav_historical
64950090110rxnav_historical
68071026606rxnav_historical
68071026660rxnav_historical
68308014510rxnav_historical
68462020401rxnav_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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEKVK-TECH, INC.338b5391-e5f7-40a2-8b15-57f47cbc48132026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 10702-023-06
ndc (package): 10702-023-01
ndc (product): 10702-023
ndc11 (package): 10702002306
ndc11 (package): 10702002301
rxcui: 1049696
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEANI Pharmaceuticals, Inc.5df92fed-6194-4905-9ef2-9eed0d2e80862026-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 62559-167-01
ndc (product): 62559-167
ndc11 (package): 62559016701
rxcui: 1049696
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDENovel Laboratories, Inc.69410bf3-0d3a-41f9-b10a-c4ee3770f7282023-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 40032-950-50
ndc (package): 40032-950-01
ndc (package): 40032-950-03
ndc (product): 40032-950
ndc11 (package): 40032095001
ndc11 (package): 40032095050
ndc11 (package): 40032095003
rxcui: 1049696

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 · 4 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
5df92fed-6194-4905-9ef2-9eed0d2e8086oxyCODONE HCl 5 MG Oral Capsule [PSN] · oxycodone hydrochloride 5 MG Oral Capsule [SCD]211These highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for OXYCODONE HYDROCHLORIDE CAPSULES. OXYCODONE HYDROCHLORIDE capsules for oral use, CII Initial U.S. Approval: 195020260122
338b5391-e5f7-40a2-8b15-57f47cbc4813oxyCODONE HCl 5 MG Oral Capsule [PSN] · oxycodone hydrochloride 5 MG Oral Capsule [SCD]211These highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for OXYCODONE HYDROCHLORIDE CAPSULES. Oxycodone Hydrochloride capsules for oral use, CII Initial U.S. Approval: 195020251113
69410bf3-0d3a-41f9-b10a-c4ee3770f728oxyCODONE HCl 5 MG Oral Capsule [PSN] · oxycodone hydrochloride 5 MG Oral Capsule [SCD]27These highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for OXYCODONE HYDROCHLORIDE CAPSULES. Oxycodone Hydrochloride capsule for ORAL use, CII Initial U.S. Approval: 195020231209
566ef74d-5c0b-49bf-9619-e757d16431efoxyCODONE HCl 5 MG Oral Capsule [PSN] · oxycodone hydrochloride 5 MG Oral Capsule [SCD]25These highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for OXYCODONE HYDROCHLORIDE CAPSULES. Oxycodone Hydrochloride Capsules CII Initial U.S. Approval: 195020181212

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
338b5391-e5f7-40a2-8b15-57f47cbc4813These highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for OXYCODONE HYDROCHLORIDE CAPSULES. Oxycodone Hydrochloride capsules for oral use, CII Initial U.S. Approval: 1950KVK-TECH, INC. | AVANTHI INC.20260909
5df92fed-6194-4905-9ef2-9eed0d2e8086These highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for OXYCODONE HYDROCHLORIDE CAPSULES. OXYCODONE HYDROCHLORIDE capsules for oral use, CII Initial U.S. Approval: 1950ANI Pharmaceuticals, Inc.20260122
338b5391-e5f7-40a2-8b15-57f47cbc4813These highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for OXYCODONE HYDROCHLORIDE CAPSULES. Oxycodone Hydrochloride capsules for oral use, CII Initial U.S. Approval: 1950KVK-TECH, INC. | AVANTHI INC.20251113
061cf52b-4432-422d-a97b-c3e1f8c4bab6These highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for OXYCODONE HYDROCHLORIDE CAPSULES. Oxycodone Hydrochloride capsules for oral use, CII Initial U.S. Approval: 1950Genus Lifesciences Inc.20240112
69410bf3-0d3a-41f9-b10a-c4ee3770f728These highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for OXYCODONE HYDROCHLORIDE CAPSULES. Oxycodone Hydrochloride capsule for ORAL use, CII Initial U.S. Approval: 1950Novel Laboratories, Inc.20231209
d57345c9-19cf-4d12-a7b1-e0c5f78d5198These highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for OXYCODONE HYDROCHLORIDE CAPSULES. Oxycodone Hydrochloride capsules for oral use, CII Initial U.S. Approval: 1950Mayne Pharma Commercial LLC | Catalent Greenville, Inc.20230705
6eaff86d-3b90-499e-b46f-316a35f5d811These highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for OXYCODONE HYDROCHLORIDE CAPSULES. Oxycodone Hydrochloride capsules, for oral use, CII Initial U.S. Approval: 1950Lannett Company, Inc.20220727
566ef74d-5c0b-49bf-9619-e757d16431efThese highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for OXYCODONE HYDROCHLORIDE CAPSULES. Oxycodone Hydrochloride Capsules CII Initial U.S. Approval: 1950Glenmark Pharmaceuticals, Inc | Genus Lifesciences Inc20181212
6ccd4ed2-eb16-4411-9b3b-ebdc5f9bab21National Council for Prescription Drug Programs20130213
116be920-8290-4598-8e89-6104584ce1f5National Council for Prescription Drug Programs20120724
3147c7dc-c342-4538-bd49-e101ae662797National Council for Prescription Drug Programs20120724
941de1d3-2a79-4c22-b801-702e3c7d3e68National Council for Prescription Drug Programs20120724
f7ee0910-32de-4c9b-a32d-20f8e35c5a3bNational Council for Prescription Drug Programs20120724
444d5f08-e491-4ff7-bf35-c26ae972f3ffOXYCODONE HCL C-II TABLETS - 5 MGSTAT Rx USA LLC | PSS World Medical Inc.20120501
9ee2fa21-b80d-449a-8e36-260cc79ef600oxycodone hydrochloride 5mg Capsulebryant ranch prepack20100308

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
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE2
CODESANDAANDA202773
CODESANDAANDA204752
CODESANDAANDA205177
CODESSNOMEDCT322691007
CODESVUID4005155
NAMESPrescribable SynonymoxyCODONE HCl 5 MG Oral Capsule
NAMESTallman SynonymoxyCODONE hydrochloride 5 MG Oral Capsule
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary
SOURCESSourceUS Edition of SNOMED_CT
SOURCESSourceVeterans Health Administration National Drug File