FDA.reportPublic FDA data

acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral Tablet [Endocet]

RxCUI
1049216
RxNorm name
acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral Tablet [Endocet]
Display name
ENDOCET (Oral Pill)
Full name
acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral Tablet [Endocet]
Term type
SBD
Status
Active
Strength
325-10 mg
Dose form
Tab
Route
Oral Pill
Updated
2026-10-17 23:43:37

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
012011
Active start
012011
Multiple ingredient
YES
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
acetaminophen325 MG / 1 EACHacetaminophenacetaminophen
oxycodone hydrochloride10 MG / 1 EACHoxycodoneoxycodone hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Tablet317541

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
acetaminophen161
oxycodone7804

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STREndocet 10/325 Oral Tablet1NAMES
RxNorm Nameacetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral Tablet [Endocet]1NAMES
RxNorm Synonym
3 linked values
3NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID
3 linked values
3CODES
RxCUI10492161CODES
MMSL_CODEBD84841CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
60951-712-7060951-712ENDOCET Oxycodone and AcetaminophenPar Health USA, LLCANDA040330
72162-1728-172162-1728ENDOCET Oxycodone and AcetaminophenBryant Ranch PrepackANDA040330

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA04033060951-712ENDOCET Oxycodone and AcetaminophenANDAPar Health USA, LLC

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 42 matching rows.

NDC11, Source, Active table
NDC11SourceActive
60951071270rxnav_ndcsyes
63629218701rxnav_ndcsyes
72162172801rxnav_ndcsyes
00043032510rxnav_historical
00043032550rxnav_historical
10544038402rxnav_historical
10544038428rxnav_historical
10544038430rxnav_historical
10544038484rxnav_historical
16590092530rxnav_historical
16590092540rxnav_historical
16590092545rxnav_historical
16590092560rxnav_historical
16590092571rxnav_historical
16590092572rxnav_historical
16590092575rxnav_historical
16590092583rxnav_historical
16590092590rxnav_historical
33358013020rxnav_historical
33358013040rxnav_historical
33358013060rxnav_historical
35356076260rxnav_historical
35356076290rxnav_historical
42549058402rxnav_historical
42549058428rxnav_historical
42549058430rxnav_historical
42549058484rxnav_historical
60951071275rxnav_historical_indirect
60951071285rxnav_historical_indirect
68387094112rxnav_historical
68387094130rxnav_historical
68387094160rxnav_historical
68387094190rxnav_historical
71335218201rxnav_historical
71335218202rxnav_historical
71335218203rxnav_historical
71335218204rxnav_historical
71335218205rxnav_historical
71335218206rxnav_historical
71335218207rxnav_historical
71335218208rxnav_historical
71335218209rxnav_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
ENDOCETOXYCODONE AND ACETAMINOPHENPar Health USA, LLC944d3e60-7eee-11de-a413-0002a5d5c51b2025-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 60951-712-70
ndc (product): 60951-712
ndc11 (package): 60951071270
rxcui: 1049216
ENDOCETOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack7dc10b86-c6cd-4012-b7b9-b694ccf4f7682024-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 72162-1728-1
ndc (product): 72162-1728
ndc11 (package): 72162172801
rxcui: 1049216
ENDOCETOXYCODONE AND ACETAMINOPHENBryant Ranch Prepackf11f356e-967d-4099-9d87-5497790b397c2024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
ndc11 (package): 71335218206
ndc11 (package): 71335218204
ndc11 (package): 71335218205
ndc11 (package): 71335218203
ndc11 (package): 71335218202
ndc11 (package): 71335218208
ndc11 (package): 71335218201
ndc11 (package): 71335218209
ndc11 (package): 71335218207
rxcui: 1049216

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 · 5 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
1b847d11-3382-458c-ae65-579d0b0d9a4bENDOCET 10 MG / 325 MG Oral Tablet [PSN] · acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral Tablet [Endocet] [SBD] · APAP 325 MG / Oxycodone Hydrochloride 10 MG Oral Tablet [Endocet] [SY] · Endocet 10/325 (oxycodone HCl / APAP) Oral Tablet [SY] · Endocet 10/325 Oral Tablet [SY]5104ENDOCET ® Oxycodone and Acetaminophen Tablets, USP CII Rx only Revised: June 202420240808
7dc10b86-c6cd-4012-b7b9-b694ccf4f768ENDOCET 10 MG / 325 MG Oral Tablet [PSN] · acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral Tablet [Endocet] [SBD] · APAP 325 MG / Oxycodone Hydrochloride 10 MG Oral Tablet [Endocet] [SY] · Endocet 10/325 (oxycodone HCl / APAP) Oral Tablet [SY] · Endocet 10/325 Oral Tablet [SY]5102ENDOCET ® Oxycodone and Acetaminophen Tablets, USP CII Rx only Revised: June 202420240827
f11f356e-967d-4099-9d87-5497790b397cENDOCET 10 MG / 325 MG Oral Tablet [PSN] · acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral Tablet [Endocet] [SBD] · APAP 325 MG / Oxycodone Hydrochloride 10 MG Oral Tablet [Endocet] [SY] · Endocet 10/325 (oxycodone HCl / APAP) Oral Tablet [SY] · Endocet 10/325 Oral Tablet [SY]5102ENDOCET ® Oxycodone and Acetaminophen Tablets, USP CII Rx only Revised: June 202420240812
944d3e60-7eee-11de-a413-0002a5d5c51bENDOCET 10 MG / 325 MG Oral Tablet [PSN] · acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral Tablet [Endocet] [SBD] · APAP 325 MG / Oxycodone Hydrochloride 10 MG Oral Tablet [Endocet] [SY] · Endocet 10/325 (oxycodone HCl / APAP) Oral Tablet [SY] · Endocet 10/325 Oral Tablet [SY]555ENDOCET ® Oxycodone and Acetaminophen Tablets, USP CII Rx only Revised: December 202520251201
fbed0f64-1143-4439-8f03-88f393d20390ENDOCET 10 MG / 325 MG Oral Tablet [PSN] · acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral Tablet [Endocet] [SBD] · APAP 325 MG / Oxycodone Hydrochloride 10 MG Oral Tablet [Endocet] [SY] · Endocet 10/325 (oxycodone HCl / APAP) Oral Tablet [SY] · Endocet 10/325 Oral Tablet [SY]5120110510

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
944d3e60-7eee-11de-a413-0002a5d5c51bENDOCET ® Oxycodone and Acetaminophen Tablets, USP CII Rx only Revised: December 2025Par Health USA, LLC20251201
7dc10b86-c6cd-4012-b7b9-b694ccf4f768ENDOCET ® Oxycodone and Acetaminophen Tablets, USP CII Rx only Revised: June 2024Bryant Ranch Prepack20240827
f11f356e-967d-4099-9d87-5497790b397cENDOCET ® Oxycodone and Acetaminophen Tablets, USP CII Rx only Revised: June 2024Bryant Ranch Prepack20240812
1b847d11-3382-458c-ae65-579d0b0d9a4bENDOCET ® Oxycodone and Acetaminophen Tablets, USP CII Rx only Revised: June 2024Bryant Ranch Prepack20240808
944d3e60-7eee-11de-a413-0002a5d5c51bENDOCET ® Oxycodone and Acetaminophen Tablets, USP CII Rx only Revised: June 2024Par Health USA, LLC20240625
72ca0d3f-ceba-4007-9a3c-560f536a2ab2National Council for Prescription Drug Programs20130213
da026507-4805-41ba-a24d-560ff3d1cfcbNational Council for Prescription Drug Programs20130213
0a55230d-93c6-423c-9380-e6b0e20bafdcNational Council for Prescription Drug Programs20120724
f82591ea-6737-4057-b435-5a17cafbe91fNational Council for Prescription Drug Programs20120724
fbed0f64-1143-4439-8f03-88f393d20390STAT RX USA LLC20110510

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCN02BEAnilidesATC1-4acetaminophen
ATCN02AANatural opium alkaloidsATC1-4oxycodone
FDASPLN0000175690Opioid AgonistEPChas_epcoxycodone
FDASPLN0000175684Full Opioid AgonistsMOAhas_moaoxycodone
MEDRTD000082AcetaminophenCHEMhas_ingredientacetaminophen
MEDRTD010098OxycodoneCHEMhas_ingredientoxycodone
MEDRTD010098OxycodoneCHEMhas_ingredientoxycodone hydrochloride
MEDRTD001249AsthmaDISEASEci_withoxycodone hydrochloride
MEDRTD001249AsthmaDISEASEci_withoxycodone
MEDRTD004342Drug HypersensitivityDISEASEci_withoxycodone hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withoxycodone
MEDRTD004342Drug HypersensitivityDISEASEci_withacetaminophen
MEDRTD005334FeverDISEASEmay_preventacetaminophen
MEDRTD005334FeverDISEASEmay_treatacetaminophen
MEDRTD005955Glucosephosphate Dehydrogenase DeficiencyDISEASEci_withacetaminophen
MEDRTD007415Intestinal ObstructionDISEASEci_withoxycodone hydrochloride
MEDRTD007415Intestinal ObstructionDISEASEci_withoxycodone
MEDRTD007418Intestinal Pseudo-ObstructionDISEASEci_withoxycodone
MEDRTD007418Intestinal Pseudo-ObstructionDISEASEci_withoxycodone hydrochloride
MEDRTD008107Liver DiseasesDISEASEci_withacetaminophen
MEDRTD010146PainDISEASEmay_treatacetaminophen
MEDRTD010146PainDISEASEmay_preventacetaminophen
MEDRTD010149Postoperative PainDISEASEmay_treatoxycodone hydrochloride
MEDRTD010149Postoperative PainDISEASEmay_treatoxycodone
MEDRTD011247PregnancyDISEASEci_withoxycodone
MEDRTD011247PregnancyDISEASEci_withoxycodone hydrochloride
MEDRTD012131Respiratory InsufficiencyDISEASEci_withoxycodone hydrochloride
MEDRTD012131Respiratory InsufficiencyDISEASEci_withoxycodone
MEDRTN0000175684Full Opioid AgonistsMOAhas_moaoxycodone hydrochloride
MEDRTN0000175684Full Opioid AgonistsMOAhas_moaoxycodone
MEDRTN0000000108Prostaglandin Receptor AntagonistsMOAhas_moaacetaminophen
MEDRTN0000175439AnalgesiaPEhas_peoxycodone hydrochloride
MEDRTN0000175439AnalgesiaPEhas_peoxycodone
MEDRTN0000175724Central Nervous System Activity AlterationPEhas_peacetaminophen
MEDRTN0000008635Decreased GI MotilityPEhas_peoxycodone
MEDRTN0000008635Decreased GI MotilityPEhas_peoxycodone hydrochloride
MEDRTN0000008701Decreased Medullary Respiratory DrivePEhas_peoxycodone
MEDRTN0000008701Decreased Medullary Respiratory DrivePEhas_peoxycodone hydrochloride
MEDRTN0000008768Decreased Organized Electrical ActivityPEhas_peoxycodone
MEDRTN0000008768Decreased Organized Electrical ActivityPEhas_peoxycodone hydrochloride
MEDRTN0000008836Decreased Prostaglandin ProductionPEhas_peacetaminophen
MEDRTN0000009072Hypothalamic Endocrine Activity AlterationPEhas_peacetaminophen
MEDRTN0000009353Increased Histamine ProductionPEhas_peoxycodone hydrochloride
MEDRTN0000009353Increased Histamine ProductionPEhas_peoxycodone
MEDRTN0000175725Peripheral Nervous System Activity AlterationPEhas_peacetaminophen
MEDRTN0000000026Hepatic MetabolismPKhas_pkacetaminophen
MEDRTN0000000042Renal ExcretionPKhas_pkacetaminophen

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH325 MG / 10 MG
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE2
CODESANDAANDA040330
NAMESPrescribable SynonymENDOCET 10 MG / 325 MG Oral Tablet
NAMESTallman Synonymacetaminophen 325 MG / oxyCODONE hydrochloride 10 MG Oral Tablet [Endocet]
NAMESTallman SynonymAPAP 325 MG / oxyCODONE Hydrochloride 10 MG Oral Tablet [Endocet]
NAMESTallman SynonymEndocet 10/325 (oxyCODONE HCl / APAP) Oral Tablet
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon